Glossary of Terms and Acronyms
- incidental prisoner subjects
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Subjects who become incarcerated (a prisoner) after they have already enrolled in a study. See also: prisoner.
- Individual Investigator Agreement
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This is a formal written agreement between an institution conducting research and an independent investigator who is collaborating on the research, by which the institution agrees…
- individually identifiable health information
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As defined by the HIPAA regulations, this is a subset of health information, including demographic information collected from an individual, and; Is created or received by…
- Information Statement
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University of Washington (UW) Human Subjects Division (HSD) term for a document used to provide information to research participants when the requirement for written consent has…
- informed consent
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A person’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research. In giving informed consent, subjects may not waive or…
- Institutional Biosafety Committee (IBC)
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The IBC evaluates human gene transfer investigations focusing on public protection (i.e., research personnel, care givers, general public, etc.) This review complements IRB review; both are…
- Institutional Review Board (IRB)
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A review body established in accordance with the federal regulations for protecting the rights and welfare of human research subjects. Most human subjects research must be…
- Investigational Device Exemption (IDE)
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Exemption from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices across state lines for use in clinical investigations.
- Investigational New Drug (IND)
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An Investigational New Drug (IND) application is the document submitted to the Food and Drug Administration (FDA) for permission to conduct a clinical study using a…
- IRB Authorization Agreement
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An agreement that authorizes one institution to provide IRB review for another. See: REQUEST External IRB Review See also: Federalwide Assurance (FWA)