Subjects who become incarcerated (a prisoner) after they have already enrolled in a study. See also: prisoner.
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…
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…
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…
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…
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…
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…
Exemption from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices across state lines for use in clinical investigations.
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…
An agreement that authorizes one institution to provide IRB review for another. See: REQUEST External IRB Review See also: Federalwide Assurance (FWA)
The IRB of record is an IRB that assumes IRB responsibilities for another institution or independent investigator for a specific study, group of studies, or for…
An ethical principle discussed in the Belmont Report requiring fairness in the distribution of research burdens and benefits; often expressed in terms of treating persons of…
A Legally authorized representative (LAR) is an individual or judicial or other body authorized under applicable law to make decisions on behalf of another individual. LARs…
Informed consent for research participation is legally effective when it is obtained and documented from the subject or the subject’s legally authorized representative in a manner…
Protected Health Information (PHI) that excludes specific individual identifiers as described in HIPAA regulations. (UW Medicine Privacy Policy COMP.103)
Medicare will not pay for an item of service to the extent that payment has been made or can reasonably be expected to be made by…
The University of Washington applies the definition of minimal risk provided in the specific federal regulations that apply to a particular study. When federal regulations do…
The term commonly used by the University of Washington research community to refer to the expedited review process, as in “Minimal Risk review”.
See: child; See also: assent
A minor change to a study approved by the UW Institutional Review Board (IRB) neither materially increases risk, nor materially decreases benefit, when considered in light…