Research Integrity Office
An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g. headache following spinal tap or intestinal bleeding associated with aspirin therapy).
Adverse Event (AE)
Any untoward physical or psychological occurrence in a human subject participating in research. An AE can be any unfavorable or unintended event including 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, or any risk associated with the research or the research intervention, or the assessment.
The IRB has reviewed the study and made a determination that the study has met all requirements. Subjects may be enrolled in the study.
Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research. Mere failure to object to the research may not be construed as assent.
A formal written, binding commitment that is submitted to a federal agency in which an entity promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved.
• Federal-Wide Assurance (FWA) An agreement between a federally funded entity and OHRP that stipulates methods by which the entity will protect research participants (66 Fed Reg 19139, 19141 April 13, 2001.)
• Multiple Project Assurance (MPA) An agreement between an entity and OPRR that stipulates the methods by which the entity will protect the rights and welfare of research participants. Under OHRP, MPAs will be replaced by FWAs.
A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).
An officer of an entity with the authority to speak for and legally commit the entity to comply with requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research.
A person authorized to make decisions on behalf of another person. In human subjects research, an individual or judicial or other body may be authorized to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others.
A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.
A valued or desired outcome; an advantage.
Any therapeutic serum, toxin, anti-toxin or analogous microbial produce applicable to the prevention, treatment, or cure of diseases or injuries.
An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted[45 CFR 46.401(a)].
A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.
Closure See Study Closure.
Having either a psychiatric disorder ( e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder ( e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.
Technically, a legal term, used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. See also Incompetence, Incapacity.
Adherence to all the trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory and institutional requirements.
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 Committee See TTUHSC OP 10.8
Consent See Informed Consent.
Periodic review of a research study by an IRB to evaluate whether risks to participants are reasonable in relation to potential benefits and to verify that the study continues to meet regulatory and institutional requirements. Continuing review shall be conducted at intervals appropriate to the degree of risk but not less than once per year. [45 CFR 46.109(e); 21 CFR 56.109(f)]
An agreement; as used here, an agreement that a specific research activity will be performed at the request, and under the direction, of an entity providing funds. Research performed under the contract is more closely controlled by the entity than research performed under a grant.
Data and Safety Monitoring Board
A committee of scientists, physicians, statisticians, and others that collects and analyzes data during the course of a clinical trial to monitor for adverse effects and other trends (such as an indication that one treatment is significantly better than another, particularly when one arm of the trial involves a placebo control) that would warrant modification or termination of the trial or notification of subjects about new information that might affect their willingness to continue in the trial.
Device (Medical) See Medical Device.
A federal agency: U.S. Department of Health and Human Services; formerly the Department of Health, Education and Welfare (DHEW).
The IRB has reviewed the study and determined that it is not approved and may not receive further review.
All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records; and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.
Any chemical compound that may be used on or administered to humans as an aid in the diagnosis, treatment, cure, mitigation, or prevention of disease or other abnormal conditions.
Exempt research is research determined by the Institutional Review Board (IRB) to involve human subjects only in one or more of certain minimal risk categories [38 CFR 16.101(b)].
Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.
Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.
Term often used to denote a therapy (drug, device, procedure) that is unproven or not yet scientifically validated with respect to safety and efficacy. A procedure may be considered "experimental" without necessarily being part of a formal study (research) to evaluate its usefulness.
Food and Drug Administration; an agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services.
The product of conception from implantation until delivery [45 CFR 46.202].
Full Board Review
Review of proposed research at a convened meeting at which a majority of the voting 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 voting members present at the meeting.
Federal-Wide Assurance (FWA) See Assurance.
Financial support provided for research study designed and proposed by the Principal Investigator(s). The granting agency exercises no direct control over the conduct of approved research supported by a grant.
An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care[45 CFR 46.402(3)].
Health Insurance Portability and Accountability Act of 1996.
Human In Vitro Fertilization
Any fertilization involving human sperm and ova that occurs outside the human body.
Human Research Protection Office (HRPO)
Office responsible for the oversight and direction of the human research protection program at TTUHSC, which includes administrative oversight of the IRB, the TTUHSC Research Compliance Program and TTUHSC Educational requirements for human research.
Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains; (1) data through intervention or interaction with the individual; or (2) identifiable private information.
IDE See Investigational Device Exemptions.
Refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Often used as a synonym for incompetence. See also Incompetence.
Technically, a legal term meaning inability to manage one's own affairs.
Often used as a synonym for incapacity. See also Incapacity.
IND See Investigational New Drug.
A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the entity or agents thereof from liability for negligence.
Institutional Review Board (IRB)
A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.
Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home).
Investigational New Drug or Device
A drug or device permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing.
A device or pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects.
Literally, &in glass& or &test tube;& used to refer to processes that are carried out outside the living body, usually in the laboratory, as distinguished from in vivo.
Literally, &in the living body;& processes, such as the absorption of a drug by the human body, carried out in the living body rather than in a laboratory (in vitro).
IRB See Institutional Review Board.
IRB records include but are not limited to: all minutes of IRB meetings, a copy of all proposals reviewed including all amendments, investigator brochures, and any supplemental information including recruitment and informational materials, consent forms, information submitted for continuing review, all correspondence, and IRB membership with a resume for each member.
Internet Medical Research Information System-the software through which all IRB applications, reviews and approvals are submitted and through which information is communicated between investigators and the IRB.
An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.
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.
A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body. Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in the participant's daily life or during the performance of routine physical or psychological examinations or tests [45 CFR 46.102(i); 21 CFR 50.3(k)]. In research involving prisoners, minimal risk is also defined as 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. [45 CFR 46.303(d)].
The collection and analysis of data as the project progresses to assure the appropriateness of the research, its design and subject protections.
Multiple Project Assurance (MPA) See Assurance.
Member of an Institutional Review Board who has no ties to the parent entity, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker).
Office for Human Research Protections (OHRP)
The office within the U.S. Department of Health and Human Services, responsible for implementing DHHS regulations [45 CFR Part 46] governing research involving human subjects.
Parent(s) or guardian's written agreement to the participation of their child or ward in research.
PI See Principal Investigator.
The period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery [45 CFR 46.202].
Any individual involuntarily confined or detained in a penal entity. The term is intended to encompass individuals sentenced to such an entity under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal entity, and individuals detained pending arraignment, trial, or sentencing.
IRB or another review body which reviews requests to use or disclose Private Health Information (PHI) for research purposes without authorization under HIPAA.
Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data.
The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.
A quorum is defined as a majority of the voting members appointed to the IRB membership. In the case of the IRB, a quorum must include at least one member whose primary concerns are in non-scientific areas. At meetings of the IRB, a quorum must be established and maintained for the deliberation and vote on all matters requiring a vote.
Systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge[45 CFR 102(d)].
Respect for Persons
An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.
Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys. Case control studies are an example of this type of research.
Review (of Research)
The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis.
The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk".
Serious Adverse Event (SAE)
A SAE is defined as death; a life threatening experience; hospitalization (for a person not already hospitalized); prolongation of hospitalization (for a patient already hospitalized); persistent or significant disability or incapacity; congenital anomaly and/or birth defects; or an event that jeopardizes the subject and may require medical or surgical treatment to prevent one of the preceding outcomes.
A person or other entity that initiates a clinical investigation, but that does not actually conduct the investigation, i.e., the test article is administered or dispensed to, or used involving, a subject under the immediate direction of another individual. A person other than an individual (e.g., a corporation or agency) that uses one or more of its own employees to conduct an investigation that it has initiated is considered to be a sponsor (not a sponsor-investigator) and the employees are considered to be investigators.
All components of a research project.
Study approved by the IRB can be closed by the investigator, the sponsor, the IRB, TTUHSC, or by an affiliated entity. See Administratively Closed.
Study completed as approved by IRB, including data analysis, and finalized.
IRB approval is suspended/terminated and all research activity halted as the result of unanticipated problems involving risks to subjects or others; serious or continuing noncompliance with 45 CFR Part 46; or the requirements or determinations of the IRB(See Sections 5.6, 5.7). Requires prompt reporting to federal regulatory authorities and TTUHSC pursuant to federal Assurance and 45 CFR Part 46.
Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.
The IRB has reviewed the study and determined that extensive changes are necessary. The study will be re-reviewed by once changes have been made.
Unexpected Adverse Event
An UAE is any adverse event and/or reaction, the specificity or severity of which is not consistent with the informed consent, current investigator brochure or product labeling. Further, it is not consistent with the risk information described in the general investigational plan or proposal.
Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate(or to continue to participate) in a research activity.