Closure of an IRB-approved study or of an application for any type of HSD determination or UW IRB approval that is initiated by HSD (not the…
Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), system, or disease temporally…
Applicable clinical trial (ACT) is the term used in Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to designate…
Regulatory term. Agreement to participate in research by an individual who is not competent to give legally valid informed consent (e.g., a child or cognitively impaired…
Regulatory term. A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research…
See: reliance agreement
An individual’s right to consider alternatives, make choices, and act without undue influence or interference of others. See: Belmont Report
A report that sets out the basic ethical principles governing research involving human subjects, which are the ethical basis of the federal human subjects regulations. Issued…
An ethical principle discussed in the Belmont Report that entails an obligation to promote good (or benefits). It refers to the balance between the risks and…
In the research context, something of positive value derived from research procedures. Per federal regulatory guidance, payments, gifts, course credit, etc. for research participation are not…
The Human Subjects Division (HSD) defines this as the ability of an individual to understand the choices presented, to appreciate the implications of choosing one alternative…
See: Single IRB
Person who has not attained the legal age (as defined by a state or country) for consent to the treatment or procedures involved in the research….
A research study that prospectively assigns one or more human subjects to one or more interventions (which may include placebo or other control) to evaluate the…
This is a web-based registry and results database for clinical studies. It is maintained by the federal government to provide patients, their family members, health care…
For more information about closing IRB applications See: Close your IRB Application
This is the name for the rules and regulations published in the Federal Register by the executive departments and agencies of the federal government. The CFR…
Data set in which direct subject identifiers have been replaced with a study code. The link between the study code and direct subject identifiers are kept…
In human subjects research, coercion occurs when an overt or implicit threat of harm (such as loss of services or access to programs to which the…
Research that engages more than one institution and for which there is a division of labor among the institutions (i.e., the institutions are not all conducting…