Abstain: is when an IRB member does not vote on a protocol under review.
Administrative Hold: An action placing specific research activities on hold temporarily to allow for additional information to be obtained. "Under the regulations an administrative hold is a suspension of IRB approval."
Adverse Event: Any untoward or undesirable experience associated with participation in the research activity.
Allegation of non-compliance: as an unproven assertion of non-compliance.
Amendment: Any change to an IRB-approved study protocol regardless of the level of review it receives initially.
Assent: is the agreement by a child, or an adult who lacks full decision-making capacity to participate in a research or clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent. [45 CFR 46.402(b)] [21 CFR 850.3 (n)]
Assurance: is an agreement between an Organization and a federal agency that stipulates that the Organization will comply with the agency's regulatory requirements. [45 CFR 46.103]
Belmont Report: A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.
Biomedical Research: Research that is conducted to contribute to an increased understanding of disease processes, new treatments and interventions, and the prevention and control of infectious and chronic diseases in clinical medicine and public health; and research involving human biological specimens (i.e. collecting or accessing tissues or genetic material for research purposes).
Central Institutional Review Board Initiative (CIRB): The CIRB is a separate IRB open to investigators who conduct adult and pediatric National Cancer Institute clinical trials.
Collaborative IRB Training Initiative (CITI): An Internet-based set of educational modules on the protection of human participants in research. It is sponsored by a consortium of IRB professionals and researchers from universities and medical schools across the country and is administered by the University of Miami .
Clinical Trial: A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.
Coercion: The act or practice of coercing. Power or ability to coerce.
Complainant: An individual who reports sensitive information to Tulane University's IRB regarding potential non-compliance issues or research activities that have potentially placed participants or others at increased risk in relationship to the conduct of the research.
Confidentiality: Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.
Conflict of Interest: "For the purposes of human research a situation where an individual's personal or financial interest competes with that individual's obligation to protect the rights and welfare of subjects."
Continuing Non-compliance: A pattern of repeated actions or omissions taken by an Investigator that indicates a deficiency in the ability or willingness of an Investigator to comply with Federal regulations, Tulane University IRB Policy, or determinations or requirements of the Tulane University IRB.
Continuing Review: is the periodic review of a research study by an IRB to evaluate whether the study continues to meet organizational and regulatory requirements. Federal regulations stipulate that continuing review should be conducted at intervals appropriate to the level of risk involved in the study, and not less than once per year. [45 CFR 46.109(e)] [21 CFR 56.109(f)].
Consultant: An individual whose expertise is required by the Principal Investigator to perform the research (A consultant may be a paid or unpaid contributor).
Data and Safety Monitoring: A plan to oversee the implementation of a study protocol for compliance monitoring.
Database: IRB database that maintains electronic information on all IRB protocols.
Data Safety Monitoring Board (DSMB): is a process that reviews the integrity, safety and progress of a research protocol with the purpose of protecting participants during the course of study and makes decisions regarding continuance, modification, or stopping of the study for reasons of efficacy or safety. A DSMP may take a variety of forms, such as an investigator reviewing his or her own data, a review by another faculty member not otherwise involved in the conduct of the research, a committee of investigators, an independent committee, or an independent data and safety monitoring board. The type safety monitoring that is adequate depends on the specifics of the research.
Data Safety Monitoring Committee (DSMC): Another term for DSMB.
De-Identified Information: De-identified health information neither identifies nor provides a reasonable basis to identify an individual. There are two ways to de-identify information; either: 1) a formal determination by a qualified statistician; or 2) the removal of specified identifiers of the individual and the individual's relatives, household members, and employers is required, and is adequate only if the covered entity has no actual knowledge that the remaining information could be used to identify the individual.
Department of Health and Human Services (DHHS): The United States government's agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.
Deviation: An incident involving noncompliance with the protocol, but one that typically does not have a significant effect on the subject's rights, safety or welfare, and/or on the integrity of the resultant data. Deviations may result from the action of the participant, Investigator, or staff. NOTE: This definition may not match the PI or Sponsor's definition.
Directed Audit: These audits are conducted by the University Research Compliance Officer to assess the Investigator's compliance with federal regulations, state and local laws, and IRB policies and procedures. These audits of IRB approved research studies are in response to identified concern(s). Concerns may be identified by the IRB Committee, an external source (e.g. OHRP, FDA or Sponsor), or an internal source (e.g. participant family member, or Institutional personnel).
Disapprove: When a protocol does not meet IRB requirements for approval and no changes and/or modifications can be implemented to improve risk to subjects.
Emergency Use: the use of an FDA-regulated test article on a human subject 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.
Exempt Review: Studies determined by the IRB to meet the exempt criteria as defined by the Federal Regulations. Exempt studies do not require periodic review by the IRB unless a change in the project is planned.
Existing Data Set: Data that existed prior to the initiation of a research project.
Expedited Review: "A review procedure that does not require review by the convened IRB that is applicable to studies determined by the IRB to meet the expedited criteria as defined by the Federal Regulations."
Expiration: When continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically and all research activities must stop until the protocol is renewed.
Expired Study: When continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically.
Finder's Fee: Compensation of any type (cash, office or medical supplies, educational stipends, gift certificates, priority in authorship listings, travel reimbursement, or anything else of value) to an individual made in exchange for referral or recruitment of a participant to a research study. Such payments, generally, are made to residents, physicians, nurses, or others in a position to identify potential participants that might qualify for enrollment into a study. The fee is paid only for participants who are actually enrolled into the study.
Finding of non-compliance: as a proven assertion of non-compliance."
Food and Drug Administration (FDA): An agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services.
Federal Wide Assurance (FWA): means a document that fulfills the requirements of 45 CFR Part 46 and is approved by the Secretary of Health and Human services. Tulane University has an approved FWA on file with DHHS. Tulane University's FWA number is 2055. A copy of the Federal-wide Assurance is available on the web site.
Full-Board Review: Review of proposed research at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.
Greater than Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. In the case of research involving prisoners "minimal risk" means that the probability and magnitude of physical or psychological harm are greater than that normally encountered in the daily lives, or in the routing medical, dental, or psychological examination of healthy persons.
HIPAA: Health Insurance Portability and Accountability Act of 1996. HIPAA governs the use and disclosure of protected health information (PHI) that is created or received by a covered entity that relates to:
- ″ The physical or mental health of an individual (living or decreased)
- ″ The provision of health care
- ″ The payment for health care
- ″ Identifies the individual or reasonably may be used to identify the individual
Give individuals the following rights
- ″ Right to request restrictions on use or disclosure of their PHI
- ″ Right to access medical records (including research records)
- ″ Right to amend medical records
- ″ Right to an accounting of disclosure of their PHI
- ″ Right to request alternate confidential communications
- ″ Right to lodge complaint with covered entity and/or the Department for Health and Human Services
Administrative Requirements
- ″ Covered Entity must designate a Privacy Official
- ″ Covered Entity must develop policies and procedures that are HIPAA Compliant
- ″ Covered Entity must provide privacy training to the workforce
- ″ Covered Entity must implement administrative, technical and physical safeguards to protect the privacy of PHI
- ″ Covered Entity must develop sanctions for violations of the HIPAA Privacy Rule
- ″ Covered Entity must meet the documentation requirements
Hold for Further Information (Table): When a protocol requires major changes before approval can be granted.
Independent Ethics Committee (IEC): A specially constituted review body whose responsibility is to ensure the protection of the rights, welfare and safety of research participants. An IEC shares the same composition and operations as an Institutional Review Board.
Informed Consent: means the agreement to participate in research that is made voluntarily by an individual with legal and mental competence and the requisite decision-making capacity, after disclosure of all material information about the research. Informed Consent means the knowing consent of an individual or his legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion. Information conveyed in the informed consent/authorization procedure must include all essential elements listed in Section 5 of this manual.
Institutional Official: An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and social/behavioral research.
Institutional Review Board (IRB): is an independent committee comprised of scientific, non-scientific, and non-affiliated members established according to the requirements of federal regulations. Any board, committee, or other group formally designated by an organization to review research involving humans as participants, to approve the initiation of and conduct periodic review of such research. The term includes, but is not limited to Institutional Review Boards, Investigational Review Boards, Central Review Boards, Independent Review Boards, and Cooperative Research Boards. [45 CFR 46.402(g)] [21 CFR 50.3(i)]
Investigator: is an individual who actually conducts research. In the event of research conducted by a team of individuals, is the responsible leader of that team. [21 CFR 50.3(d)]
Investigational Device: A device whose safety or effectiveness are being evaluated where the term "device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:
- ″ Recognized in the official National Formulary, or the United States Pharmacopeia, 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.
- ″ Intended to affect the structure or any function of the body of man or other animals, and which does not achieve 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 its primary intended purposes."
Investigational Drugs/Investigational Biologics (Test Articles): A new drug or biologic that is used in a clinical investigation. The term investigational biologic also includes a biological product that is used in vitro for diagnostic purposes. Investigational drugs or biologics may include:
- ″ Products that are not generally recognized as being safe and effective for any use under the conditions prescribed, recommended, or suggested by the FDA; or
- ″ Products already approved by the FDA as safe and effective for specific indications that are being studied for new indications (or doses, strengths, or frequency).
Investigator-Initiated: When an investigator develops the study protocol. IRB Approval: The determination of the IRB that the research study has been reviewed and may be conducted at an institution with the constraints set forth by the IRB and by other institutional and Federal requirements.
IRB Committee Member: An individual appointed by the Senior Vice President for Research or designee to serve on the IRB.
IRB of Record: An IRB is considered the IRB of record when it assumes IRB responsibilities for another institution and is designated to do so through an approved Assurance with OHRP. A Memorandum of Understanding is required designating the relationship for Tulane University to serve as the IRB of Record.
Lapsed Protocol: A protocol that has not been approved prior to the expiration.
Local Research Context: Knowledge of the institution and community environment in which human research will be conducted.
Memorandum of Understanding (MOU): A formal agreement between Tulane University and another institution that identifies the Tulane University Institutional Review Board as the IRB of record for that institution and defines the responsibilities for both he Tulane IRB and the other institution.
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 daily life or during the performance of routine physical or psychological examinations or tests. An example of minimal risk is the risk of drawing a small amount of blood from healthy individual for research purposes (because the risk of doing so is no greater than the risk of doing so as part of a routine physical examination). In the case of research involving prisoners "minimal risk" means that the probability and magnitude of physical or psychological harm is that normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
Non-Affiliated Member: Member of an Institutional Review Board who has no ties to the parent institution, its staff, or faculty and whose immediate family members have not ties to the parent institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, home maker).
Non-Compliance: "Failure to follow the regulations or the requirements and determinations of the IRB."
Non-Significant Risk (NSR) Device: An NSR device investigation is one that does not meet the definition for a significant risk study. NSR device studies, however, should not be confused with the concept of "minimal risk," a term utilized in the IRB regulations to identify certain studies that may be approved through an "expedited review" procedure.
Office for Human Research Protections (OHRP): The office under the Department of Health and Human Service (DHHS) responsible for implementing the DHHS regulations (45 CFR 46) governing biomedical and social/behavioral research involving human participants.
Office of Research Administration (ORA): This Office is responsible for oversight of the Grants and Contracts including Clinical Trials.
Performance Site: A site where research is performed.
Performance Site(s) Engaged in Research: A performance site becomes "engaged" in human subject's research when its employees or agents 1) intervene or interact with living individuals for research purposes, or 2) obtain individually identifiable private information for research purposes. Further, a performance site is considered to be "engaged" in human subjects' research when it receives a direct Federal award to support the research.
Performance Sites Not Engaged in Research: A "performance site is not engaged in human subjects research if its employees or agents do not 1) intervene or interact with living individuals for research purposes, and do not 2) obtain individually identifiable private information for research purposes. "
Periodic Compliance Review: Random assessments of the internal IRB department and external departments or sites involved in the conduct of human subjects research at Tulane University conducted by the University Research Compliance Officer or TUOHRP Director. These reviews are used to evaluate proper execution and accurate documentation of an IRB approved research project. Internal compliance reviews monitor the adherence to federal regulations, state and local law, and IRB policies and procedures as well as accurate documentation between the IRB database and the IRB paper files. External compliance reviews monitor the adherence to federal regulations, state and local law, Tulane University IRB policies and procedures, adherence to the study protocol, accurate documentation and reporting of study related activities, and evaluations/observation of the informed consent process.
Private Information: As defined by DHHS regulations means 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).
- ″ "Research involving human subjects" means any activity that either:
- ″ Meets the DHHS definition of "research" and involves "human subjects" as defined by DHHS; or
- ″ Meets the FDA definition of "research" and involves "human subjects" as defined by FDA. ″
- "Research" as defined by DHHS regulations means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(d)]
- ″ "Human Subject" as defined by DHHS regulations means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [45 CFR 46.102(f)]
- ″ "Intervention" as defined by DHHS regulations means both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. [45 CFR 46.102(f)]
- ″ "Interaction" as defined by DHHS regulations means communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)]
- ″ "Identifiable information" as defined by DHHS means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).
- ″ "Research" as defined by FDA regulations means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3©, 21 CFR 56.102©]
- ″ "Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act" means any use of a drug other than the use of an approved drug in the course of medical practice. [21 CFR 312.3(b)]
- ″ "Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act" means any activity that evaluates the safety or effectiveness of a device. [21 CFR 812.2(a)] ″ "Any activity in which results are being submitted to or held for inspection by FDA as part of an application for a research or marketing permit is considered to be FDA-regulated research. [21 CFR 50.3©, 21 CFR 56.102©]"
- ″ "Human Subject" as defined by FDA regulations means an individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3(g), 21 CFR 56.102(e)] A human subject includes an individual on whose specimen a medical device is used. [21 CFR 812.3(p)]
Protected Health Information (PHI): Individually identifiable health information including demographic data that relates to:
- ″ The individual's past, present or future physical or mental health or condition,
- ″ The provision of health care to the individual, or
- ″ The past, present, or future payment for the provision of health care to the individual, ″ And that identifies the individual or for which there is a reasonable basis to believe can be used to identify the individual. Individually identifiable health information includes many common identifiers (e.g., name, address, birth date, Social Security Number).
Protocol Changes: Investigator's request to amend and/or changes to the protocol.
Provisionally Approve: A protocol that requires minor changes prior to approval.
Quality Assurance Reviews: Quality Assurance reviews are performed by the TUOHRP Director and office staff to verify that the electronic database is consistent with the IRB paper files and the paper files are collated in accordance with IRB policy and procedure.
Quality Improvement (QI): Periodic examination of organizational activities, policies, procedures and performance to identify best practices and target areas in need of improvement; includes implementation of corrective actions or policy changes where needed.
Quorum: A majority of voting members of an IRB, including at least one member whose primary expertise is in a nonscientific area.
Related: An event is "related" if in the opinion of the investigator it is likely to have resulted from participation in the research study."
Research Misconduct: Any fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
Risk: the probability of harm or injury (physical, psychological, social, legal, or economic) occurring as a result of participation in a research study. Both the probability and magnitude may vary from minimal to significant.
Risk-Potential Benefit Profile: An evaluation of the risks and potential benefits that have occurred during the course of the study.
Serious Adverse Event: Ad adverse event that results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
Serious Non-Compliance: An action or omission taken by an Investigator that any other reasonable Investigator would have foreseen as compromising the rights and welfare of a participant.
Significant Risk (SR) Device: An SR device study is defined as a study of a device that presents a potential for serious risk to the health, safety, or welfare of a subject and (1) is intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or (4) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
Social/Behavioral Research: Research involving the study of social and behavioral human functioning at the individual, small group, institution, or community levels. The study of behavioral factors such as thought processes, personality and emotion; also, the study of social and environmental variables are examples. Methodologies include direct observation, interviews and surveys, etc.
Sponsor-Imposed Suspension: A determination from the sponsor of the study to place specific research activities on hold. This determination may be made for interim data analysis; inadequate drug availability; response to a DSMB report/recommendation; or a pre-planned stopping point.
Student Investigator: A Tulane University student who actually conducts research. In the event of research conducted by a student and/or students, is the responsible leader of that team. [21 CFR 50.3(d)]
Suspension of IRB Approval: An action initiated by the IRB or other officials of the organization to stop temporarily some or all research procedures pending future action by the IRB or by the Investigator or his/her study personnel.
Termination of IRB Approval: An action initiated by the IRB or other officials of the organization to stop permanently some or all research procedures.
Unanticipated: An event is "unanticipated" when it was unforeseeable at the time of its occurrence.
Unanticipated Problems Involving Risk to Subjects or Others: Any problem (including any event or information) that is (1) unforeseen and (2) indicates that subjects or others are at increased risk of harm."
Unexpected Adverse Event: Any adverse event of the specificity or severity is not consistent with the current Investigator Brochure; or, if an Investigator Brochure is not required or available, the specificity or severity of which is not consistent with the risk information described in the general investigational plan or elsewhere in the currently approved IRB Protocol. For example, under this definition, hepatic necrosis would be unexpected (by virtue of greater severity) if the Investigator Brochure only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the Investigator Brochure only listed cerebral vascular accidents.
University Research Compliance Officer (URCO): Responsible for the oversight of the University's Research Compliance Program.
Vice President for Research (formerly ASVPR): responsible for oversight of all research conducted at the University; Institutional Official (IO) for the Human Research Protection Program
Violation: Accidental or unintentional changes to or not compliant with the IRB approved protocol that affect the subject's rights, safety, welfare, and/or the integrity of the resultant data. NOTE: This definition may not match the PI or Sponsor's definition.
Vulnerable Populations: Individuals who lack the capacity to provide informed consent or whose willingness to participate research may be subject to undue influence or coercion. Vulnerable subjects include, for example, children, prisoners, individuals with emotional or cognitive disorders/impairments, and economically or educationally disadvantaged persons. [45 CFR 56.107] [45 CFR 56.111(a) (3)] [45 CFR 56.111(b)] [21 CFR 56.107] [21 CFR 56.111(a)(3)] [21 CFR 56.111(b)]
