participant previously completed screening and either did not complete the screening process or was determined to be ineligible.
See also: Subject Statuses
in exempt research, recorded refers to information (data) that is collected or documented during the process of a research investigation. The information may be written, typed, copied, audio or video recorded, etc.
See also: Exempt Human Subjects Research
a pre-enrollment activity used to find potential subjects.
See also: Subject Statuses
involves strategies for obtaining comparable levels of information from the use of fewer animals or for maximizing the information obtained from a given number of animals (without increasing the pain or distress) so that in the long run fewer animals are needed to acquire the same scientific information.
See also: Refinement, Replacement
individual is identified as a prospective subject during recruitment: 1) by obtaining the results of procedures performed as part of the practice of medicine, 2) by responding to recruitment activities, or 3) referred by a provider.
See also: Subject Statuses
refers to modifications of husbandry or experimental procedures to enhance animal well-being and minimize or eliminate pain and distress.
See also: Reduction, Replacement
- Regulatory Binder
essential documents are those which individually and collectively permit evaluation of the conduct of a research study and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the regulatory requirements of various federal, state and local agencies.
- Regulatory Sponsor
the agency, organization, company or person primarily responsible for initiating and overseeing the research and ensuring the study complies with federal regulations
payment for actual expenses
- Related Adverse Event
there is at least a reasonable possibility that the unexpected adverse event may have been caused by the procedures involved in the research. Possibly related should be considered more likely than not, e.g., > 50% chance that it is at least partially related should be the threshold since the alternative would not be considered a reasonable possibility)
See also: Adverse Event
- Relying Institution
Indicates the institution that is relying on another organization's IRB or IACUC (reviewing IRB or IACUC)
See also: External IRB, Reviewing IRB, sIRB
- Remote Monitoring
monitoring or auditing a study while not physically present on the UT Health campus.
See also: Onsite Monitoring, Sponsor Monitoring
refers to methods that avoid using animals. Including: 1) Absolute replacement (i.e., replacing animals with inanimate systems such as computer programs); OR 2) Relative replacement (i.e., replacing animals such as vertebrates with animals that are lower on the phylogenic scale)
See also: Reduction, Refinement
data management centers (data centers) and human specimen repositories (sometimes called registries, banks, or libraries) are used to store data and/or specimens for future use. When the use is for research purposes, the data centers/repositories must be approved by the Institutional Review Board (IRB). Human Specimen Repositories collect, store, and distribute human tissue/specimen materials for research purposes. Repository activities involve three components: (i) the collectors of tissue samples; (ii) the repository storage and data management center; and (iii) the recipient investigators. Human repository repositories may be combined with data management centers.
See also: Collector
a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
The Belmont Report provides addition clarification:
“…the term "research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective."
Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. Some research development or testing and evaluation may also meet this definition.
See also: Clinical Investigation, Generalizable Knowledge
- Research Misconduct
Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion.
See also: Fabrication, Falsification, Plagiarism
- Research Only
a procedure or activity performed solely for the study.
physical (manual or mechanical) or chemical (anesthetic or tranquilizer not used in conjunction with surgery) means to limit some or all of an animals normal movement or behavior.
- Retrospective Research
the research involves data or specimens that already exist in their entirety at the time of IRB submission.
- Reviewing IRB
or "designated IRB" indicates the IRB reviewing on behalf of relying institutions.
See also: External IRB, Relying Institution, sIRB
a potential harm described in terms of probability (chance) and magnitude (severity).
Generally in research, risks of research that a reasonable person, in what the investigator knows or should know to be the subject’s position, would be likely to consider significant in deciding whether or not to participate in the research should be disclosed to the potential subject.
Risks may be physical, social, legal, economic or psychological in nature, and may relate to employability or insurability. In addition, risks may apply to the individual subject or may apply to a broader segment of the society
Risk is usually discussed in terms of two factors probability (chance) and magnitude (severity). In order to minimize the risk, the researcher and the IRB need to assess the chances the risk will occur and how severe that risk can be, then look at the mechanism or methods built into the research for decreasing both the chance and severity.
For example, risk that a metal object may become a projectile during an MRI procedure. The severity could be high, but if precautions are taken the probability is low.
Additionally in certain circumstances additional parameters of risk such as permanence and immediacy should be included in the description of risk in research. For example it may improve a potential subjects understanding of the risk and assist them in deciding whether or not to participate, if for some risks they were told whether the effect might be permanent rather than self limiting or at least treatable and for some risks the subject should be informed whether they should only expect this effect immediately or whether it might occur after the have left the care of the researcher in which case might they need emergency care.
See also: Benefit
- Run In/Wash Out
applicable to interventional study, indicates a pre-intervention step commonly involving a run-in or wash out of study interventions.