Glossary
Unanticipated Adverse Device Effect
serious adverse effect on health or safety; or any life-threatening problem; or death caused by, or associated with, a device, if: not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a Device that relates to the rights, safety, or welfare of subjects.
See also:Unanticipated Problem Involving Risk to Subjects or Others
any incident, experience or outcome that meets all of the following criteria:
1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied (note: the unfounded classification of a serious adverse event as anticipated constitutes serious non-compliance);
2) related or probably related to participation in the research; and
3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Unapproved Device
a device that is used for a purpose or condition for which the device requires, but does not have, an approved application for premarket approval.
See also:Undue Influence
the offer of inducements excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. It also argues that “unjustifiable pressures” occur when “persons in positions of authority … urge a course of action for a subject.” This includes manipulating a prospective subject’s choice by utilizing the “influence of a close relative.” Lastly issues may be raised as potential undue influence when judgment may be compromised by financial incentives especially when the subject is not the recipient of the financial incentive. Undue influence needs to be distinguished from coercion for the purposes of UTHSCSA IRB applications of policy. Coercion is considered the use of a threat of harm or punishment to influence behavior; e.g., in general, payments do not constitute coercion per se. There are also less apparent examples of vulnerability to undue influence such as Institutional vulnerability and Deferential vulnerability to undue influence. Institutional is when an individual is subject to the formal authority of others which could influence the subject’s participation. Examples- prisoners, military personnel, students, employees. Deferential is similar to institutional but arises from informal relationships characterized by inequities in social status (gender, race, class) power or knowledge (doctor-patient relationship), or cognitive ability (elderly person defer to adult kids). Heightened concern that subject’s decision re: participation not truly voluntary. Deferential vulnerability can be very subtle- investigators must be especially sensitive to potential for subjects to believe refusing to participate will negative impact their future treatment. Investigators need to be sensitive to such deference and assess whether subject is truly exercising his/her autonomy and adjust the informed consent accordingly (a suggested addition to the usual consent process might include discussing participation in absence of the individual to whom the potential subject ordinarily defers-additional because the PI or investigator with the relationship may be the best person to discuss the study and answer questions and it would not be appropriate to bypass them all together). Deferential may be misconstrued to include therapeutic misconception but it is generally a separate concept though still requiring consideration in the consent process. Where potential subjects may be drawn to research because of lack of effective standard treatments and desire to find treatment they may be prone to misunderstand the risks and potential benefits and have unreasonable expectations about potential benefits. Pay special attention to ensuring potential benefits of participation are properly characterized. Where investigator is also treating physician, in addition to the issue of deference, there exists a higher risk of therapeutic misconception. Again you may want to consider having impartial third party obtain consent or finalize the consent process in the absence of the individual to whom the potential subject ordinarily defers.
See also:Unexpected Adverse Event
any adverse event, the nature, severity, or frequency of which is not consistent with either: (1) the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in (a) the protocol related documents, such as the IRB-approved research protocol, any applicable investigator brochure, and the current IRB-approved 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 adverse event and the subject's predisposing risk factor profile for the adverse event
See also:Unidentifiable
anonymous is an unidentified collection of human biological materials or data, or unlinked or anonymized, originate from identified materials or data but have been stripped by the source (not the researcher) of all identifiers or codes such that the ability to identify particular individuals via clinical or demographic information supplied with the sample, or information derived from the Research would be impossible for the investigator, the repository, or a third party.