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Graduate Program in Public Health / IRB Acronyms and Definitions
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Introduction
Acronyms
Definitions
Administrative Hold
Adverse Event (AE)
Advocate
Age of Majority
Agent (Workforce Member)
Allegation
Assent
Audit
For-Cause Audit
Not-For-Cause Audit
Quality Assurance Review
Self-Assessment Audit
Biologic Agent
Children (Minors)
Ward
Clinical Investigation
Coded
Compassionate Use
Complainant
DataandSafetyMonitoringBoard (DSMB) or “Data Monioring Committee
Data Use Agreement (DUA)
Dead Fetus
De-Identified
Delivery
Determination Letter
Emergency Research
Emergency Treatment Investigational Device Exemption (IDE) Application
Emergency Treatment Investigational New Drug (IND) Application
EmergencyUse of Test Articles
Enrollment Hold
Expanded Access (Compassionate Use)
Experimental Subject
External Event
FDA Clinical Hold
Fetus
Full Board Meeting (Convened IRB)
Generalizable Knowledge
Guardian
Human Research (Human Subjects Research)
Healthcare Operations Activity
Humanitarian Use Device Exemption (HDE)
Humanitarian Use Device (HUD)
Identifiable Information
Information (Data) Security Violation (or Breach)
Individually Identifiable Health Information (IIHI)
InformedConsent
Interaction
Internal Event
Intervention
Investigational Agent
Investigational Device
Investigational Device Exemption (IDE)
Investigational Drugs or Investigational Biologics
Investigational New Drug (IND) Application
Label
Legal Guardian
Legally Authorized Representative (LAR)
Limited Data Set
Medical Device
MinimalRisk
Department of Defense Research
Prisoner Research
Research With Non-Prisoners
Multi-Site research Study
Neonate
Non-Compliance
Continuing Non-Compliance
Minor (Non-Serious) Non-Compliance
Serious Non-Compliance
Non- Significant Risk (NSR) Device
Nonviable Neonate
Oral (Verbal) Consent
Pregnancy
Prisoner
Incarceration of a Research Participant
Privacy Versus Confidentiality
Privacy Violation (or Breach)
Private Information
Protected Health Information (PHI)
Protocol Deviation
Research
Research Misconduct
Research Participants (Human Subjects)
Reviews Preparatory to Research
Risk
Serious Adverse Event (SAE)
Significant Risk (SR) Device
Sponsor
Sponsor-Investigator
Systematic Investigation
Test Article
Unanticipated Events
Unanticipated Problem Involving Risks to Participants or Others (UPIRPO)
Unanticipated Adverse Device Effect (UADE)
Unexpected Adverse Event (UAE)
References
Authors
Review and Approval History
Introduction
Below are a list of acronyms and definitions which are commonly used by the IRB.
Acronyms
The following acronyms are used in this policy:
AcronymDefinition
AEAdverse Event
BAABusiness Associates Agreement
BRANYBiomedical Research Alliance of New York
CFRCode of Federal Regulations
CITICollaborative Institutional Training Initiative
CMSCenter for Medicare & Medicaid Services
CoCCertificate of Confidentiality
COIConflict of Interest
DMC Downstate Medical Center
DSMBData Safety Monitoring Board
DUAData Use Agreement
FDAU.S. Food and Drug Administration
FDAAAFDA Amendments Act (2007)
FWAFederal Wide Assurance
HDEHumanitarian Device Exemption
HHSU.S. Department of Health and Human Services
HIPAAHealth Insurance Portability and Accountability Act (1996)
HUDHumanitarian Use Device
IBCInstitutional Biosafety Committee
IDEInvestigational Device Exemption
IIHIIndividually Identifiable Health Information
INDInvestigational New Drug Application
IOInstitutional Official
IORGIRB Organizations
IRBInstitutional Review Board
KCHCKings County Hospital Center
LARLegally Authorized Representative
MTAMaterials Transfer Agreement
NCI CIRBNational Cancer Institution Central IRB
NIHNational Institutes of Health
NSRNon-Significant Risk
NYSDOHNew York State Department of Health
OBANIH Office of Biotechnology Activities
OCASOffice of Compliance and Audit Services
OGCOffice of the General Counsel
OHRPHHS Office for Human Research Protections
PHIProtected Health Information
PIPrincipal Investigator
QARQuality assurance review
QISQuality Improvement Subcommittee
RACNIH Recombinant DNA Advisory Committee
RESResearch Education Subcommittee of the IRB
SACHRPHHS Secretary’s Advisory Committee on Human research Protections
SAESerious Adverse Event
SRSignificant Risk
SRCScientific Review Committee
SUNYState University of New York
UADEUnanticipated Adverse Device Effect
UAEUnexpected Adverse Event
UPIRPOUnanticipated Problem Involving Risks to Participants or Others
Definitions
Most of the definitions below are based on definitions within Federal or State regulations or NY State Law.
Administrative Hold
An administrative hold is a voluntary action by an investigator to temporarily or permanently stop some or all approved research activities. Administrative holds are not suspensions or terminations. Protocols on administrative hold remain open and require continuing review.
Adverse Event (AE)
An adverse event (or AE) is any untoward physical or psychological occurrence in a research participant. An AE can be any unfavorable and unintended event including an abnormal laboratory finding, symptom, or disease associated with the research or the use of a medical investigational test article. An AE does not necessarily have to have a causal relationship with the research.
See Also: serious adverse event (SAE), unexpected adverse event (UAE)
Advocate
An individual who has the background and experience to act in, and agrees to act in, the best interest of a research participant (e.g., child who is a ward, cognitively impaired adult, oncology patient, other vulnerable individual) during the informed consent process and when applicable, for the duration of the participation in the research.
Age of Majority
The legal age after a child becomes an adult, as defined by the local jurisdiction where the research takes place.
See related: children.
Agent (Workforce Member)
An individual who acts on behalf of the DMC including but not limited to DMC employees, faculty, staff, residents, fellows, students, contractors, consultants, temporary workers, volunteers, or other authorized third party entities and personnel.
Allegation
Any substantive written or oral statement or other communication of possible noncompliance made to a DMC Official or an IRB Member. An unproven assertion of noncompliance.
Assent
A child's or a cognitively impaired adult’s affirmative agreement to participate in research. Mere failure to object in the absence of an affirmative agreement, should not be misconstrued as assent.
Audit
For-Cause Audit
An audit that is directed by the Institutional Official (IO), IRB, IRB Chair, IRB Vice Chair, Executive Director of the Human research Protection Programs, Assistant Vice President, or Office of Compliance and Audit Services (OCAS) in circumstances that require an on-site record review generally related to reported or suspected noncompliance. This is an in-depth examination of all components of a research study including, but not limited to all records and documents, observations of processes, and interviews with investigators, research staff members, and participants for the purpose of determining if the rights and welfare of participants are being upheld according to federal regulatory and IRB requirements.
Not-For-Cause Audit
A quality assurance audit directed by part of the IRB audit plan and schedule. Criteria used to select studies for a not-for-cause audit vary and are approved by the IRB Steering Committee on an annual or as needed basis. Investigators may also request to be on the schedule for a not-for-cause audit to ensure continuing compliance in their research studies by contacting the IRB. IRB staff members make every effort to include these requested audits on the schedule, but do have to prioritize based on current workload and risk assessment. Participating in a scheduled audit can provide valuable education for all research staff as well as the PI.
Quality Assurance Review
A Quality assurance review (QAR) may be requested by investigators or required by the IRB. The QAR provides verbal feedback to the PI and/or research staff members participating in the review following its completion. Written reports are not generated, and only aggregate data will be kept by the staff. Results are not linked to investigators or their studies.
Self-Assessment Audit
A Self-assessment audit is carried out by a member of the PI’s study team or a peer. These may be done on a voluntary basis by the PI, or required by the IRB. Results must be reported to the IRB. Contact the IRB for a Self-Assessment Audit Tool.
Biologic Agent
A biological agent (biologic) is a medical product. Many biologics are made from a variety of natural sources, such as humans, animals or microorganisms. Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biological products include:
- Vaccines
- Blood and blood products for transfusion and or manufacturing into other products
- Allergenic extracts, which are used for both diagnosis and treatment, such as allergy shots
- Human cells and tissues used for transplantation, such as tendons, ligaments and bone
- Gene therapies
- Cellular therapies
- Tests to screen potential blood donors for infectious agents, such as HIV
- In general, the term "drugs" includes therapeutic biological products
Children (Minors)
Persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction (18yearsinthe StateofNewYork)in which the research will be conducted.
If research takes place in other states, the definition of a child is defined by the age of majority in the state where the research takes place, and may range from 16-21. If the research plan includes recruiting children outside of New York State, the PI must follow the state definitions of child, parent, and legal guardian in that jurisdiction.
Children may also be referred to as minors.
Ward
A child who is placed in the legal custody of the state or other agency, institution or entity, consistent with applicable federal, state or local law.
Clinical Investigation
Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more research participants. An experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.
Clinical investigation means any experiment that involves a test article and one or more research participants and that either is subject to requirements for prior submission to the FDA, or is not subject to requirements for prior submission to the FDA, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that are subject to FDA provisions regarding nonclinical laboratory studies (e.g., in vivo or in vitro experiments).
Coded
Codedrefers to1) identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and 2) a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.
Coded data or specimens are considered to be identifiable unless the specific rules are followed to convert coded private information or specimens to de-Identified as outlined in the “IRB Approval Decision Aid”.
See related: de-identified and limited data sets.
Compassionate Use
See: expanded access.
Complainant
A person alleging that an activity or event is non-compliant.
DataandSafetyMonitoringBoard (DSMB) or “Data Monioring Committee
Acommitteeofscientists,physicians, statisticians, and others,generallyestablished bythestudysponsor,thatcollectsandanalyzes data duringthecourse ofaclinical trialto monitor foradverse effectsandother trends(such as anindication thatone treatmentissignificantlybetter than another,particularlywhenone armofthetrial involves aplacebo control)thatwouldwarrantmodification ortermination ofthetrial or notification of research participants about newinformationthatmightaffecttheirwillingnessto continueinthe trial.
Data Use Agreement (DUA)
An agreement established when an institution releases a limited data set that establishes the ways in which the information in the limited data set may be used and how it will be protected.
Dead Fetus
Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.
De-Identified
De-identified describes data sets (including data about specimens) that meet the following criteria:
- All HIPAA identifiers listed in HIPAA-6 policy are remove from the data set OR a qualified statistician has 1) determined that the risk is very small that research participants can be identified and 2) documented the methods and results of the analysis, AND
- The identity of the research participants cannot be readily ascertained by the investigator or be associated with the information, AND
- There is no actual knowledge that it would be possible to identify the participant.
Note: For FDA regulated studies (e.g., in-vitro device studies using de-identified specimens), the FDA may exercise enforcement discretion to not require informed consent as described in the FDA Guidance for "In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable" (click here).
For related information see: coded.
See HIPAA-6 Policy:
See policy on De-identification of Information.
Delivery
Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other means.
Determination Letter
An IRB determination letter documents when an activity does not need IRB approval.
Emergency Research
Emergency research refers to the study of acute, life-threatening clinical situations. Often, informed consent from the participants is not feasible because the participant lacks the capacity to provide their own consent (e.g., unconscious) and/or there is insufficient time because treatment must be promptly administered. The conduct of planned emergency Human research or clinical trials in life-threatening emergent situations requires special consideration by the IRB, including consideration of whether consent may be waived. The specific conditions under which prospective consent of the participant may be waived for planned emergency research are provided by 21 CFR 50.24 and OHRP guidance on Informed Consent Requirements in Emergency research.
Emergency Treatment Investigational Device Exemption(IDE) Application
A mechanism through the FDA for providing eligible participants with investigational devices for the treatment of an immediate serious or life-threatening illness for which there are no satisfactory alternatives.
Emergency Treatment Investigational New Drug (IND) Application
A mechanism through the FDA for providing eligible participants with investigational drugs, agents or biologics for the treatment of an immediate serious or life-threatening illness for which there are no satisfactory alternatives.
EmergencyUse of Test Articles
Thesingle clinical useofaninvestigational (or unlicensed) drug, biologic, or devicewitha patient in alife-threateningsituationinwhichnostandardacceptable,effectivetreatmentis availableand inwhichthere isnotsufficienttime toobtainIRBapproval.
Enrollment Hold
AnactionbytheIRB, sponsor, or PI, or senior leadership, whichprohibits the enrollmentofnew research participants.
Expanded Access (Compassionate Use)
Expanded access, sometimes called compassionate use, is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA).
For more information see the FDA Website on Expanded Access (Compassionate Use).
Experimental Subject
As defined by Department of Defense, or DoD, research involving a human being as an experimental subject is an activity, for research purposes, where there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction [32 CFR.210.102 (f) reference (c)]. Examples include, but are not limited to, a physical procedure, a drug, a manipulation of the subject or subject's environment, and the withholding of an intervention that would have been undertaken if not for the research purpose.
See also: research participant and intervention.
External Event
A problem or event involving research participants enrolled by other institutions in multicenter research projects that fall under the purview of an external IRB, that is, not the DMC IRB.
FDA Clinical Hold
An FDA clinical hold is an order issued by FDA to the sponsor of an IND application to delay a proposed clinical investigation or to suspend an ongoing investigation. All or some of the investigations conducted under an IND application may be placed on clinical hold.
Fetus
Fetus means the product of conception from implantation until delivery.
Full Board Meeting (Convened IRB)
An IRB meeting which takes place to review research that is not eligible for expedited or exempt review. In order for the research to be approved, the meeting must be specifically constituted and carried out in accord with federal regulations and this policy.
Generalizable Knowledge
Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions or inform policy (i.e., knowledge gained from a study may be applied to populations outside of the specific study population). For conclusions to be generalized, they must actually be disseminated for research purposes (or be part of a program of investigation that will be disseminated).
A useful definition of dissemination is that the material will be shared beyond the local setting.
- Obvious examples of dissemination are publication in a scholarly journal, presentation at a professional conference, or placement of a report in a library.
- Examples that are not dissemination include oral presentation to a DMC Department in fulfillment of a DMC requirement, sharing of results with an agency that cooperated in information collection, or internal presentation for utilization and review purposes.
Examples of generalizable knowledge:
- The findings from the activity involving a patient population at DMC can be applied to a population outside of the DMC.
- The findings from a population within a healthcare network can be applied to a population outside of the network.
- The findings of a student research project can be applied to other students in another school.
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 (Human Subjects Research)
In order for research to be considered human (subjects) research, it must involve living individuals about whom an investigator conducting research obtains 1) data through an intervention or interaction with the individual, or 2) obtains individually identifiable private information.