Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
CATEGORY A DEVICE
Experimental/Investigational – Innovative devices believed to be in class III for which absolute risk of the device type has not been established (i.e., initial questions of safety and effectiveness have not been resolved and the FDA is unsure of whether the device type is safe and effective).
CATEGORY B DEVICE
Non-experimental/Investigational – Non-experimental and/or investigational devices believed to be in class I or II or devices believed to be in class III where the incremental risk is the primary risk in question (i.e., underlying questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA approval for that device type.
CLINICAL INVESTIGATION (modified FDA definition)
Any experiment in which a drug is administered or dispensed to, or used, involving one or more human subjects. An experiment is any use of a drug except for the use of a marketed drug strictly in the course of medical practice.
CLINICAL RESEARCH RECORDS
Documentation of research procedures and results, and documentation of clinical care rendered to subjects and clinical findings.
A prospective research study involving interaction with human subjects and clinical intervention to evaluate the safety or efficacy of a treatment or diagnostic modality. Treatment may include drugs, devices, biologics or surgical procedures.
CLINICAL TRIAL (ICMJE)
Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.
Facts and conditions that may favor a decision to allow a conflicted Investigator to participate in a research project. For example, when the individual having such interests is uniquely qualified by virtue of expertise and experience and the research could not otherwise be conducted as safely or effectively without the individual, he or she may be permitted in the study to the extent prescribed by the Research Conflict of Interest Committee (RCOIC). See the Research Conflict of Interest page for more information.
Changes requiring only the concurrence of the principal investigator (PI) or non-substantive clarifications, that, when met, will allow the release of the IRB approval.
CONFLICT OF INTEREST (IRB MEMBERS)
Any situation where an IRB member, consultant, or Chair, or his/her family members has any significant financial or non-financial interest which has the potential to bias the design, conduct, reporting, or reviewing of research.
The level of review for human subject research activities at an IRB meeting where a quorum of IRB members is present.
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) 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, or (3) 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.
ENGAGED IN RESEARCH
In general, an institution is considered engaged in a non-exempt human subjects research project when its employees or agents obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. See OHRP guidance for more information.
Members who serve on the IRB by virtue of their office.
The level of review of human subject research activities for (1) certain kinds of research involving no more than minimal risk and that fall within a category listed in the Federal Register 63 FR 60364-60367, November 9, 1998;and (2) for minor changes in approved research [45 CFR 46.110; 21 CFR 56.110].
FACILITIES AND ADMINISTRATIVE (F&A) COSTS
Also referred to as indirect costs. These are indirect costs that are incurred for common or joint objectives, and therefore, cannot be identified readily and specifically with a particular sponsored project, instructional activity, or any other institutional activity. In its 1996 revision of OMB Circular A-21, the federal government replaced the term “indirect costs” with “facilities and administrative costs.” See the F&A Primer for more information.
FAMILY (Research Conflict of Interest)
All persons related by blood or marriage, other financial dependents, or a person in an intimate relationship.
FAMILY (IRB Member Conflict of Interest)
Immediate familial relationships, including parents, spouse, children, step parents, step children, siblings, grandparents, grandchildren, father-in-law, and mother-in-law.
- presenting, publishing, or sharing the findings (via internet, professional conference, peer-reviewed journal, etc.) to a group of scholars, practitioners, or scientists in order to illuminate a topic or issue within one's field of study;
- the findings are applied to some population in addition to the study sample;
- the findings can be replicated by others.
Used subjectively at the discretion of the IRB to convey a sense of magnitude of research-related risk that is greater than moderate risk. High risk studies may include those involving cardiac or back device implants.
Payments in recognition of a special service or distinguished achievements for which custom does not typically set a fixed price (e.g. panel participation, reviewing manuscripts, leading group discussions, and similar services).
HUMAN SUBJECT (as defined by 21 CFR 50)
An individual (healthy human or patient) who is or becomes a participant in research, either as a recipient of the test article or as a control.
HUMAN SUBJECT (as defined by 45 CFR 46)
A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
HUMANITARIAN DEVICE EXEMPTION (HDE)
Medical devices approved for marketing typically must have demonstrated safety and efficacy before marketing to the public-at-large. The exemption allows marketing even though the HUD does not have proven efficacy for its labeled indication.
HUMANITARIAN USE DEVICE (HUD)
A medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year [21 CFR 814.3(n) ].
Salary, consulting payments, honoraria, royalty payments, dividends, loans from the entity, or any other payments or consideration with value – including those received for lectures, seminars, and/ or teaching engagements.
The voluntary agreement of a participant, or their legally authorized representative, to take part in research after being provided with sufficient information about the study, in a language and terminology understandable to them, and sufficient opportunity to consider their decision. [45 CFR 46.116, and if applicable, 21 CFR 50.25]
INFORMED CONSENT DOCUMENTS
Informed Consent Form, Assent for Minors, Assent for Impaired Adults, California Bill of Rights, HIPAA Authorization, Specimen, Genetics
INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL
The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements. [45 CFR 46.102(h), and, if applicable, 21 CFR 56.102(m)].
INTERACTION (as defined by 45 CFR 46)
Communication or interpersonal contact between investigator and subject.
INTERNATIONAL CONFERENCE ON HARMONIZATION; GOOD CLINICAL PRACTICE (ICH-GCP)
Standards for the design, conduct, monitoring, auditing, recording, analysis and reporting of studies that provide assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of subjects are protected. In the U.S., the standards are set forth in the Code of Federal Regulations (CFR); ICH has been adopted as guidance. In Europe, the standards are set forth in ICH E6 Guidelines for Good Clinical Practice. Studies may be governed by CFR, ICH or both standards, as set forth in the clinical trial agreement.
INTERVENTION (as defined by 45 CFR 46)
Includes both physical procedures by which data are gathered and manipulation of the subject or the subject’s environment that are performed for research purposes.
The principal investigator, co-investigator, significant personnel and any other person who participates in the design, conduct, or reporting of any portion of a research project.
IRB MEMBER AGENDA PACKET
This includes the agenda, applicable educational materials, minutes, Report of Interim Administrative Actions, Outline of Research Reports – Full Board Review of Extension Requests; and for new protocol submissions, the application form, informed consent document(s), assent (if applicable), and protocol, or protocol summary.
IRB APPLICATION PACKAGE
Includes the application form, abstract, informed consent document(s), protocol or protocol summary, investigator’s brochure, recruitment materials, and appendices.
The individual designated by the President to provide leadership and expertise for the overall IRB review process and serves as the primary representative of the IRB for the institution.
Persons listed on the Office of Human Research Protection (OHRP) Membership Roster, and includes both primary and alternate voting members.
LEGALLY AUTHORIZED REPRESENTATIVE
An individual or judicial or other body authorized under applicable law (i.e. California Health and Safety Code § 24178) to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research [45 CFR 46.102(c) and, if applicable, 21 CFR 50.3(l)].
Means greater than 50%.
MEDICAL EXPERIMENT (as defined by California Health and Safety Code 24174)
(a) The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, as defined in Section 109920 or 109925, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject. (b) The investigational use of a drug or device as provided in Sections 111590 and 111595. (c) Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject.
MINIMAL ADDITIONAL RISK
Used subjectively at the discretion of the IRB to convey that the risks associated with research procedures are minimal regardless of the risk involved in standard care procedures associated with the subject’s underlying condition. Thus for regulatory purposes, “minimal additional” is a minimal risk category.
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. [45 CFR 46.102(i)]
MINOR INCREASE OVER MINIMAL RISK
Regulatory term for studies involving children.
Used subjectively at the discretion of the IRB to convey a sense of magnitude of research-related risk that is greater than minimal. Moderate risk studies may include those involving experimental drugs.
A percentage of company valuation or in dollar amount (current market value if publicly traded; internal estimate of value if not publicly traded; otherwise, amount of investment). May be in the form of stock, stock options, real estate, or any other investment or ownership vehicle.
PEDIATRIC POST-MARKET SURVEILLANCE
Pediatric post-market surveillance involves careful review of adverse experiences with devices used in children after approval and marketing. Such surveillance for any device may be required for a Class II or Class III device, the failure of which would be reasonably likely to have serious adverse health consequences, or if the device is intended to be: (1) implanted in the human body for more than one year, or (2) a life sustaining or life supporting device that is not used only in a specialized facility (such as a dialysis machine in a dialysis center). The specific form of the surveillance program is arrived at through agreement between the manufacturer and the FDA. This form could include literature reviews.
PHS AWARDING COMPONENT
An organizational unit of the Public Health Service (e.g. NIH) that funds research.
PRINCIPAL TREATING PROFESSIONAL (PTP)
The LLUAHSC faculty physician or qualified healthcare professional who serves as the primary applicant for use of an HUD.
A voting member of the IRB chosen based upon the appropriate level of experience, educational background, and expertise to serve as the leading reviewer and presenter of human subject research reviewed at convened IRB meetings.
PRIVATE INFORMATION (as defined by 45 CFR 46)
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.
Greater than 50% of the IRB voting members present in person or connected simultaneously via speakerphone or video, including one member whose primary concerns are in a non-scientific area [45 CFR 46.108(b)]. If both the primary and alternate member are present, only the primary member counts toward quorum and voting. Conflicted members cannot count towards quorum.
A systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research and product development, but excludes quality improvement activities.
Includes Office of the Vice President for Research Affairs, Sponsored Research (IRB & IACUC office), Sponsored Projects Financial Management, Research Integrity, Technology Management and Contracts, and the Clinical Trial Center.
Probability of harm or injury, whether physical, psychological, social, or economic, occurring as a result of participation in a research study. Both the probability and magnitude of possible harm vary from minimal to moderate or high risk.
A voting member of the IRB chosen based upon the appropriate level of experience, educational background, and expertise to evaluate the assigned agenda item and serves to supplement the findings of the primary reviewer and second the motion.
SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM
An extramural research program for small businesses that was established by the awarding components of the Public Heath Service and certain other federal agencies, the Small Business Innovation Development Act as amended. For purposes of the Research Conflict of Interest policy, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program.
Categories not identified by the Federal Government, but determined by the IRB to require specific considerations for protections [Compare with Vulnerable Populations]. See Primers & Tips: Special Populations for more information.
Narrower limits imposed by the IRB (e.g. more narrowly restricted inclusion/exclusion criteria, approval for only one stage of the study, approval of fewer recruitment sites, or limitations on recruitment mechanisms). The study may begin on this limited scale, but the PI retains the option to later submit a change request to reverse the stipulation, usually after additional information or effort is accomplished.
STUDY BILLING GRID
Outline of all costs associated with the conduct of a clinical trial; it may include both routine care and research required charges.
The IRB has determined that the research reviewed has significant outstanding issues that cannot be resolved by way of requiring stipulations to the proposed research and must be resubmitted for further review.
Participation by IRB members, remote from the meeting site, being connected by telephone or video conference.
TREATING PROFESSIONAL (TP)
The LLUAHSC faculty physician or qualified healthcare professional who is responsible for guiding the treatment of the patient being diagnosed or treated with an HUD.
Any incident, experience, or outcome (including adverse events) that meets all of the following criteria: (1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied; and (2) related or possibly related to a subject’s participation in the research; and (3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Individuals who are likely to be exposed to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, handicapped or economically or educationally disadvantaged persons, and who require additional safeguards in the study to protect their rights and welfare [45 CFR 46.111(b); 21 CFR 56.111(b)]. Other populations that may be considered vulnerable, depending on study procedures and individual status, include groups such as the elderly, patients, students, and employees. [Compare with Special Populations].
WRITTEN STATEMENT (of consent)
An informational handout to be given to the prospective subject containing many, if not all, of the elements of informed consent, but without signatures.