An emancipated minor is a child who is legally considered an adult. In Washington State, emancipated minor status is not automatic for those who have simply…
Refers to a waiver of consent for emergency medicine research that involves more than minimal risk to subjects and for which it is not possible to…
The one-time clinical use of an investigational drug or device with a patient in a life-threatening or seriously disabling situation in which no standard acceptable treatment…
Refers to someone who: acts on behalf of an organization; exercises institutional authority or responsibility; or performs institutionally-designated activities.
An institution becomes “engaged” in human subjects research when its employees or agents: (1) Intervene or interact with living individuals for research purposes; or (2) Obtain…
Research that meets the definition of “human subjects research” but that is determined by HSD to be exempt from the federal human subjects regulations because it…
Expanded access is the term that refers to a group of FDA mechanisms allowing the use of an investigational drug or device outside of a clinical…
Institutional Review Board (IRB) review that is conducted by the IRB chair, or a designated voting member or group of voting members, rather than by the…
The phrase used to refer to any Institutional Review Board (IRB) other than an institution’s own IRB. For the University of Washington (UW), it refers to…
The Family Educational Rights and Privacy Act (FERPA) [20 U.S.C. § 1232g; 34 CFR Part 99] is a Federal law that protects the privacy of student…
A written agreement with the federal Department of Health and Human Services (HHS) by which an institution commits to complying with the requirements in the HHS…
The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological…
When proposed research does not meet the criteria for exempt status or expedited review, the research is reviewed at a convened meeting of the full Institutional…
An international set of quality standard for clinical care, including clinical trials involving human subjects. The standards are developed by the International Conference on Harmonisation (ICH/GCP)….
Contains provisions to protect the confidentiality and security of individually identifiable health care information about patients (Protected Health Information, or PHI) that arises in the course…
The formal documentation of consent for release of protected health information, given by either the patient or a legally authorized representative. For the authorization to be…
The Human Subjects Assistance Program (HSAP) is a discretionary no-fault program developed to provide medical and other assistance to otherwise healthy subjects who experience a research-related…
Is a status granted by the Food and Drug Administration (FDA) to devices intended for treatment or diagnosis of a disease or condition that affects no…
A medical device (1) intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in no more…
Data which are either (a) directly connected to name/other identifiers, or (b) indirectly connected via a study number or other coding scheme. Even if neither condition…