IRB: Glossary

IRB Glossary
Allegation of Noncompliance	An unproven assertion of Noncompliance.
Benign Behavioral Intervention	A behavioral Intervention that is brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on subjects, and the investigator has no reason to think the subjects will find the intervention offensive or embarrassing.
Children	Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
Classified Research	Research involving any information or material, regardless of its physical form or characteristics, that is owned by the United States Government, and determined pursuant to Executive Order 12356, April 2, 1982 or prior orders to require protection against unauthorized disclosure, and is so designated.
Clinical Investigation	A synonym for Research as defined by the FDA.
Clinical Trial	Any investigation in human subjects intended to discover or verify the effects of a drug or device, or to identify any adverse reactions to a drug or device, or to study physiology of a drug or device to ascertain its safety or efficacy.
Clinical Trial (NIH Definition)	A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on biomedical or behavioral health-related outcomes.
Committee Review	All review processes that require a convened IRB.
Compassionate Use	The use of an unapproved device on an individual in a serious situation in which the device does not have an Investigational Device Exemption (IDE), no generally acceptable alternative for the condition exists, and in which there is not sufficient time to obtain IRB approval.
Conflict of Interest	An IRB member or consultant has a conflict of interest if any of the following are true for the member/consultant or an individual in the member's Immediate Family: Being listed as an investigator or involved in the design, conduct, or reporting of the research. Having equity interest related to the research, exclusive of interests through mutual funds. Having a financial interest in the sponsor of the research or the technology being evaluated. Having a proprietary interest (or having an immediate family member with such an interest) in the research, such as a patent, trademark, copyright, or licensing agreement. Being an executive, director, or officer at the agency or company sponsoring the research. Having received compensation related to the research in the preceding 12 months or anticipated compensation related to the research. Having a financial interest in the research that either cannot be readily determined, or exceeds $5,000. Having any other conflict that may be perceived to inhibit a fair and unbiased review of the research.
Continuing Noncompliance	A pattern of Noncompliance that is likely to continue without intervention or failure to work with the IRB to resolve Noncompliance.
Designated Reviewer	An Experienced IRB Member designated to conduct Non-Committee Review.
Education Records	Those records that are: Directly related to a student; and Maintained by an educational agency or institution or by a party acting for the agency or institution. The term does not include: Records that are kept in the sole possession of the maker, are used only as a personal memory aid, and are not accessible or revealed to any other person except a temporary substitute for the maker of the record. Records of the law enforcement unit of an educational agency or institution, subject to the provisions of §99.8. Records relating to an individual who is employed by an educational agency or institution, that: Are made and maintained in the normal course of business; Relate exclusively to the individual in that individual's capacity as an employee; and Are not available for use for any other purpose. Records relating to an individual in attendance at the agency or institution who is employed as a result of his or her status as a student are education records and not excepted. Records on a student who is 18 years of age or older, or is attending an institution of postsecondary education, that are: Made or maintained by a physician, psychiatrist, psychologist, or other recognized professional or paraprofessional acting in his or her professional capacity or assisting in a paraprofessional capacity; Made, maintained, or used only in connection with treatment of the student; and Disclosed only to individuals providing the treatment. For the purpose of this definition, “treatment” does not include remedial educational activities or activities that are part of the program of instruction at the agency or institution Records created or received by an educational agency or institution after an individual is no longer a student in attendance and that are not directly related to the individual's attendance as a student. Grades on peer-graded papers before they are collected and recorded by a teacher.
Emergency Use	The use of an unapproved drug, biologic, or device on an individual in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval.
End Approval Date	The last date that a study is IRB approved and the last date that a study can be conducted without undergoing continuing review.
Experienced IRB Member	An IRB member who has gained over a period of time sufficient knowledge and skill in conducting IRB reviews to serve as Designated Reviewer.
Experimental Subject as Defined by DOD	An activity, for research purposes, where there is an Intervention or Interaction with a living individual for the primary purpose of obtaining data regarding the effect of the Intervention or Interaction.
Expiration Date	The day after the End Approval Date.
Fetus	The product of conception from implantation until delivery.
Guardian	An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
Human Research as Defined by FDA	Any activity that is Research as Defined by FDA and involves Human Subjects as Defined by FDA.
Human Research as Defined by HHS	Any activity that is Research as Defined by HHS and involves Human Subjects as Defined by HHS.
Human Research	Any activity that is Human Research as Defined by HHS or Human Research as Defined by FDA.
Human Subject as Defined by FDA	An individual who is or becomes a participant in Research as Defined by FDA, either as a recipient of the test article or as a control, or an individual on whose specimen an investigational device is used.
Human Subject as Defined by HHS	Either: A living individual about whom an investigator (whether professional or student) conducting Research as Defined by HHS obtains (1) information or biospecimens through Intervention or Interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (2) obtains, uses, studies, analyzes, or generates information that is both Identifiable Information and Private Information or Identifiable Biospecimens. Newborn dried blood spots collected after 3/15/2015 provided the research is funded by the Public Health Service Act.
Identifiable Biospecimen	A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
Identifiable Information	Information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
Immediate Family	Spouse, spousal equivalents (including domestic partners), dependents, and all members of the employee’s household.
Impartial Witness	A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the entire consent process and reads the consent document and any other written information supplied to the subject as part of the consent process.
Interaction	Communication or interpersonal contact between investigator and subject.
Intervention	Physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Legally Authorized Representative	An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject's participation in the procedure(s) involved in the research.
Meeting Chair	The IRB member running a convened IRB meeting. The Meeting Chair may be an IRB chair, an IRB vice-chair, or an IRB member temporarily designated by a Meeting Chair.
Minimal Risk	The probability and magnitude of harm or discomfort anticipated in the research that 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. The IRB interprets the phrase "Ordinarily encountered in daily life or during the performance of routine physical or physiological examination or tests" to refer to normal healthy individuals in general and exclude the risks that certain subcategories of individuals face in their everyday life. For example, the IRB does not evaluate the risks imposed in research focused on a special population against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone) or having a medical condition (e.g., frequent medical tests or constant pain). For research that involves Prisoners as subjects: 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. For research subject to Canadian oversight: The probability and magnitude of possible harms implied by participation in the research that is no greater than those encountered by subjects in those aspects of their everyday life that relate to the research.
Neonate of Uncertain Viability	A neonate after delivery that, although living, is uncertain to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.
Non-Committee Review	All review processes that do not require a convened IRB including non-human research determinations, non-engagement determinations, exemption determinations, and expedited review.
Non-significant Risk Device	An investigational device that is not a Significant Risk Device.
Noncompliance	Failure to follow the regulations or the requirements or determinations of the IRB.
Nonviable Neonate	A neonate after delivery that, although living, is unable to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.
Pregnant Woman	A woman during the period of time from implantation until delivery.
Prisoner	Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
Private Information	Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record)
Pseudonymisation	The processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person.
Public Health Authority	An agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.
Regulatory Review	Review of administrative and regulatory issues unrelated to the regulatory criteria for approval that under the regulations must be determined by a convened IRB or reviewer using the expedited procedure.
Regulatory Reviewer	Individual who conducts Regulatory Review.
Related to the Research	A financial interest is Related to the Research when the financial interest is in the sponsor or the product or service being evaluated.
Research as Defined by FDA	Any experiment that involves a test article and one or more Human Subjects as Defined by FDA, and that either must meet the requirements for prior submission to the FDA under section 505(i) or 520(g) of the Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit, where: Act: The Federal Food, Drug, and Cosmetic Act, as amended (§§201-902, 52 Stat 1040 et. seq., as amended (21 USC 321-392)) Test article: Any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 or 354-360F of the Public Health Service Act
Research as Defined by HHS	A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. DOJ regulations state that implementation of Bureau of Prisons programmatic or operational initiatives made through pilot projects do not meet this definition.
Restricted	A status for investigators indicating that new submissions will not be accepted for review.
Serious Noncompliance	Noncompliance that may adversely affect the rights and welfare of subjects.
Significant Risk Device	An investigational device that: Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject; Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
Suspension of IRB Approval	Temporary or permanent withdrawal of IRB approval for some or all research procedures short of Termination of IRB Approval.
Termination of IRB Approval	Withdrawal of IRB approval for all research procedures where the IRB does not anticipate re-opening the study.
Unaffiliated Investigator	A researcher engaged in Lehigh University-initiated or centered research who is not an employee of the university and not an agent of an outside entity that can provide IRB review.
Unanticipated Problems Involving Risks to Subjects or Others	Information that: Is unexpected (inconsistent with information previously reviewed by the IRB); and Indicates that subjects or others are at increased risk of harm because of the research study.
Vulnerable Population	A category of subjects that is vulnerable to coercion or undue influence, such as (but not limited to) children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
Wards	Children who are cared for and the responsibility of the state or any other agency, institution, or entity.
Written or In Writing	Writing on a tangible medium (e.g., paper) or in an electronic format.

References: 45 CFR §46.102, §46.202, §46.303, §46.402

21 CFR §50, §56.102, §312.3, §812.3