U

UM Event

An event which occurs in a study under the supervision of the UM IRBMED and whose PI is a UM faculty or staff member. The event is a UM Event when it occurs at UM (including any UM hospital, health center, or other facility) or any other site where the UM PI has oversight, even when the PI is physically in another location. It does not matter where the subject experiences or is treated for the Adverse Event. If interventions take place at different UM locations (e.g., the Michigan Clinical Research Unit {MCRU}), please specify at which location the event occurred.

Unanticipated

An event is when "unanticipated" when it was unforeseeable at the time of its occurrence. Unanticipated and Unexpected are not synonymous. A research protocol can monitor for an unexpected event, but cannot monitor for an unforeseen event. All unanticipated events are unexpected but not vice versa.

Unanticipated Problem Involving Risks to Subjects or Others (UPIRSO / UaP)

Often referred as an Unanticipated Problem. An unanticipated problem may be either an actual harmful or unfavorable occurrence or any development that potentially increased the likelihood of harm occurring in the future. Assessment Criteria:

1. Unanticipated Severity:  The nature, severity, or frequency of the event(s) or information was NOT expected, given descriptions in the study documents or the characteristics of the subject population being studied.
2. Related:  There is a reasonable possibility that the procedures involved in the research caused the problem.
3. Increased Risk:  The event(s) or information suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized (including physical, psychological, economic, or social harm).

Unapproved Medical Device

A device used for a purpose or condition for which the device would require but does not have pre-market approval or an approved investigational device exemption (IDE) from FDA.

Underlying condition

A disease or other circumstance affecting the research subject that is not a result of the intervention or experimental design of a research study.

Undue Influence

Excessive or inappropriate reward or other incentive in which a person is induced to act otherwise than by their own free will or without adequate consideration of the consequences.

Unexpected

Not identified by nature, severity or frequency in the current University IRB-approved research protocol or informed consent document

Unexpected Adverse Drug Reaction

A term used by some sponsors to refer to an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochures for an unapproved investigational product or package insert/summary of product characteristics for an approved product).

Unexpected Adverse Event

Any adverse event occurring in one or more subjects in a research protocol, the nature, severity, or frequency of which is not consistent with either:

1. the known or foreseeable risk of AEs associated with the procedures involved in the research that are described in (a) the IRB-approved documents (e.g., applicable investigator brochure, current protocol narrative, current informed consent document), and (b) other relevant sources of information, such as product labeling and package inserts; or
2. the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the AE and the subject’s predisposing risk factor profile for the AE.

Unexpected Magnitude, Duration or Frequency

An event or occurrence(s) should be reported to the IRBMED according to the Timeline for unexpected events when the intensity (severity), how long the event takes or persists, or the rate of occurrence is different than described in the informed consent document (ICD), even if the event is otherwise described in the ICD. For example, the ICD notes that some subjects experience mild, brief ringing in the ears following an fMRI. If a subject experiences ringing of significant intensity (such that she cannot work or attend classes) or the ringing persists for several weeks, the event would be reportable as an unexpected event. Likewise, if elevated liver enzymes were described in the ICD as expected at statistical rate of 2% but monitoring revealed 10% of subjects experienced such elevations, this should be reported as an unexpected adverse event.

Uniform Anatomical Gift Act

Legislation adopted by all 50 States and the District of Columbia that indicates procedures for donation of all or part of a decedent's body for such activities as medical education, scientific research, and organ transplantation.

Unilateral Award

An award made by a sponsor to an organization without considering competitive proposals. Unilateral awards are most often made when unsolicited proposals receive favorable treatment.

US Agency for International Development (USAID)

An independent federal government agency that receives overall foreign policy guidance from the Secretary of State. The agency works to support long-term and equitable economic growth and advancing US foreign policy objectives.

United States Code (USC)

The USC is a consolidation and codification by subject matter of the general and permanent laws of the US. For example, the USC includes all of the patent, copyright and trademark statues.

US Department of Agriculture
(USDA)

Federal agency responsible for implementation and enforcement of the Animal Welfare Act.

US Information Agency

US Government foreign affairs agency.

US Munitions List (USML)

A list of articles, services and related technical data designated as defense articles and defense services. The State Department has stated that the USML is illustrative only, meaning that the absence of an item on the USML does not conclusively rule out the possibility of it being a defense article or defense service.

US Patent and Trademark Office (PTO)

The US PTO is a non-commercial federal entity and one of 14 bureaus in the Department of Commerce. The office’s major function is the examination and issuance of patents and the examination and registration of trademarks.

Unrelated

Unassociated or without a timely relationship; evidence exists that an outcome is definitely related to a cause other than the event in question.

Unrelated Event

Any adverse event for which there is evidence that it was definitely related to a cause other than the investigational drug/agent/therapy (e.g., disease progression). Investigators must be able to provide such evidence upon request. See also Cause, Attribution, Relatedness.

Unrestricted Funds

Monies with no requirements or restrictions as to use or disposition. Grants, contracts, and cooperative agreements are considered to be restricted funds, while gifts are usually considered unrestricted funds.

Unsolicited Proposal(s)

PIs can submit proposals to a sponsor that are not in response to an RFP, RFA, or PA.

US Government Principles

US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training. Nine principles that provide a foundation for humane care and use of animals in the US.

Animal and Plant Health Inspection Service (APHIS)

APHIS is the component of the USDA that administers the Animal Welfare Act. Within APHIS, Animal Care is the agency that is responsible for ensuring compliance with the Animal Welfare Regulations.

Utility Patent

Description of a patent that relates to patent protection of compositions of matter (compounds), useful processes, and machines.

V

Vaccine

A biologic product generally made from an infectious agent or its components - a virus, bacterium, or other microorganism - that is killed (inactive) or live-attenuated (active, although weakened). Vaccines may also be biochemically synthesized or made through recombinant DNA techniques.

Variable

An element or factor that the research is designed to study, either as an experimental intervention or a possible outcome (or factor affecting the outcome) of that intervention.

Vector

A vehicle that transfers material (typically genetic) into a host cell or organism. Typically, vectors are of two types viral or non-viral. Non-viral vectors are self-replicating, circular elements that can be easily manipulated to carry genetic cargo and are easily purified in bulk; they are transferred into cells by standard laboratory techniques. Recombinant viruses that have been bioengineered to be harmless can also carry genetic cargo for transfer into cells in the laboratory, or into an entire host organism, the latter is an example of gene therapy.

Veteran’s Affairs (VA)

VAs is a government-run military veteran benefit system. The VA employs nearly 280,000 people at hundreds of VAs medical facilities, clinics, and benefits offices and is responsible for administering programs of veterans’ benefits for veterans, their families, and survivors. The benefits provided include disability compensation, pension, education, home loans, life insurance, vocational rehabilitation, survivors’ benefits, medical benefits and burial benefits. It is administered by the Secretary of VAs.

Veterans Administration Medical Center (VAMC)

Health care facility operated by the Department of Veterans Affairs.

Viable

As it pertains to a neonate, able to survive after delivery to the point of independently maintaining heartbeat and respiration. The Secretary may, from time to time, take in account medical advances and publish in the Federal Register guidelines to assist in determining whether a neonate is viable for purposes of 45 CFR 46. If a neonate is viable, then it may be included in research only to the extent permitted and in accordance with the requirements of 45 CFR 46.

Vice President for Research (VPR)

The VPR is the “institutional official” named in the Single Project or Federal Wide Assurances (FWA).  Stephen R. Forrest is the current Vice President for Research.

Violation

Accidental or unintentional changes to or noncompliance with the IRB approved protocol that affects the subject's rights, safety, welfare, and/or the integrity of the data.

Virus

A non-cellular biological entity that can reproduce only within a host cell. Viruses consist of nucleic acid covered by protein; some animal viruses are also surrounded by membrane. Inside the infected cell, the virus uses the synthetic capability of the host to produce progeny virus.

Voluntary

Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.

Vulnerable Subjects

Vulnerable populations can be defined as children, prisoners, pregnant women, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons. If vulnerable individuals are involved in clinical trials, IRBs must ensure that additional safeguards have been included to protect the vulnerable group. Safeguards may include the presence of interpreters or social workers to explain the research and ensure informed consent. IRBs have a specific obligation to protect those individuals who are particularly susceptible to coercion or undue influence (21 CFR 56.11). Studies involving vulnerable groups often pose difficult ethical questions. For example, vulnerable subjects may not be allowed to participate in research that involves more than minimal risk but conveys no benefits directly to the subjects. (21 CFR 56.11 and 45 CFR 46 Subparts B, C, D).

W

Ward

A person placed by the court under the care of a guardian.

Washout Period

Period of time without active treatment, usually scheduled before the beginning of the placebo and active treatment arms. This can refer to a required period of withdrawal from treatment before active treatment starts.

Waste material

Material originally collected for clinical or diagnostic purposes but that is no longer needed for that purpose.

Whistleblower Policy

The University Policy and Procedures for Reporting Improper Governmental Activities and Protection Against Retaliation for Reporting Improper Activities that protects employees from retaliation for reporting improper activities and addresses written complaints alleging acts of reprisal or intimidation due to disclosure of improper activities. See also Improper activity.

World Health Organization (WHO)

WHO is the directing and coordinating authority for health within the United Nations. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends. In the 21st century, health is a shared responsibility, involving equitable access to essential care and collective defense against transnational threats.