Glossary | Human Research Protections

Master Reliance Agreement:

An agreement between two or more institutions or IRBs that can cover future research. Typically, Master Reliance Agreements are used with determination forms or other mechanisms to document the implementation of the reliance agreement for specific studies.

Material Transfer Agreement:

A Material Transfer Agreement (MTA) is a document that is used by scientists and their institutions to transfer materials to other scientists and institutions. MTAs provided by outside organizations may contain clauses that are not consistent with the University of Utah policies and procedures and/or federal law. Signing one of these agreements could severely impede a scientist's ability to carry out his or her research or to publish in a timely fashion. It is important that all MTAs are evaluated and signed by an authorized TVC representative. The Technology Venture Commercialization Office handles and processes these agreements.

Medical Device:

According to the FDA, a device is: "An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes." (See: Is The Product A Medical Device?).

Minimal Risk:

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(i)). For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination. This is not interpreted to include the inherent risks certain categories of human subjects face in their everyday lives. For example, the risks imposed in research focused on a special population should not be evaluated against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone).

In addition, the IRB generally subscribes to the recommendations related to 45 CFR 46.404 from SACHRP regarding research involving children.

Minimal Risk Prisoner Research:

Minimal risk, in regard to prisoners, is defined as: the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. Note: "Harms," when referring to prisoners, are specifically described as physical or psychological and that the standard minimal risk for prisoners who are research subjects is not based on the daily life of a healthy prisoner, but refers to a healthy person as an absolute standard based on the daily lives of healthy non-incarcerated individuals.

Minor:

Any person who is under 18 years of age.

Minor Noncompliance:

Any behavior, action or omission in the conduct or oversight of research involving human subjects that deviates from the approved research plan, federal regulations or institutional policies but because of its nature, the research project or the subject population,

Does not place, or have the potential to place, participants and others at greater risk than previously anticipated;
Does not have a substantive effect on the value of the data collected; and
Does not result from willful or knowing misconduct on the part of investigators or study staff.

Examples of minor noncompliance may include, when such noncompliance does not create additional risks to subjects:

Changing study personnel without notifying the IRB;
Shortening the duration between planned study visits;
Implementing minor wording changes in study questionnaires without first obtaining IRB approval; or
Routine lab missed at scheduled visit and re-drawn later.

Modifications:

Changes requested by the IRB following review by expedited procedures or at convened meetings.

Directive Modifications: Changes requested by the IRB that are editorial or proscriptive (i.e., investigators are given specific text or parameters for addressing the changes); or confirm IRB assumptions. Minor revisions may be re-reviewed by expedited procedures.

Substantive Modifications: Changes requested by a convened IRB that relate directly to the criteria for IRB approval and require clarification or explanation from the researcher. Substantive revisions must be re-reviewed at a convened IRB meeting.

Monitoring:

A systematic, ongoing process to evaluate or oversee the conduct of research procedures.