NOHSP Definitions - M

A glossary of terms and concepts found in the Nemours HSP policies and procedures. References and resources are located in the policy noted by HSP### after each definition.

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Medical device: 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 its 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. (HSP#047)

Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in the daily life of healthy individuals or during the performance of routine physical or psychological examinations or tests. (HSP#017)

Minor changes to approved research: Minor changes to approved research: The IRB considers a modification minor if:

1. The changes do not adversely alter the overall potential harm or risk/benefit profile of the research study. And:
2. All added procedures involve no more than minimal risk AND fall into categories
   (1) - (7) of research that can be reviewed using the expedited procedure. (HSP#020)

Minor increase over minimal risk: The subjective finding of the IRB that a procedure does not meet the criteria for minimal risk, nor constitute more than a minor increase over minimal risk. The IRB may use the following criteria to determine whether the probability and magnitude of harm is only a minor, or slight, increase over minimal risk:

• Any harms associated with the procedure(s) if they occur will be transient (restricted to time of procedure or short post-experimental period) and reversible (requiring no more than a short post-experimental clinical intervention); and
• There is no, or extremely small probability that the potential pain, discomfort, stress or harm associated with the procedure(s) which subject might experience will be severe.
• The investigator has presented sufficient evidence to the IRB that criteria above are met in consideration of the specific population, the measures in place to protect participants and minimize harm, and the qualifications of the research personnel. (HSP#025)

Minor Noncompliance: Noncompliance that is neither Serious Noncompliance nor Continuing Noncompliance. (HSP#058)

More than minor increase over minimal risk: The subjective finding of the IRB that a procedure that does not meet the criteria for minimal risk or minor increase over minimal risk. (HSP#025)

“More Stringent” Standard: Compliance with the regulation or law that is most protective of the human research participants. For example, If State law requires specific, additional consent documentation for genetic testing while federal regulations do not, the state law will be followed. (HSP#055)