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Human Subjects: Federal regulations define a human subject as a living individual about whom a researcher obtains:
Investigational New Drug or Device: A drug or device permitted by the FDA to be tested in humans but that is not yet determined to be safe and effective for a particular use in the general population, and not yet licensed for marketing. Investigator: See Principal Investigator. Investigator-Sponsor: Individual with responsibilities of both initiating and conducting a clinical investigation; The obligations of an Investigator-Sponsor under the FDA requirements include both those of a Sponsor and those of an Investigator. Investigator's Brochure: A compilation of the clinical and non-clinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. It provides Principal Investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, methods of administration and safety monitoring procedures. Legally Authorized Representative: A person authorized either by statute or by court appointment to make decisions on behalf of another person. In human subjects research, 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 involved in the research. Life-threatening: Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible. Minimal risk: A risk is minimal where 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. Monitoring: The collection and analysis of data as the project progresses to assure the appropriateness of the research, its design and subject protections. Non-significant Risk Device: An investigational medical device that does not present significant risk to the patient. (See also Significant Risk Device.) 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 which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. Persons receiving care in a medical treatment setting who are also "prisoners", as defined above, can be considered for enrollment in research only as permitted for other prisoners as subjects. Protocol: The formal design or plan of an experiment or research activity; specifically the plan submitted to the IRB for review. The protocol includes a description of the rationale and objectives of the research, the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the potential risks and benefits to subjects, subject recruitment and compensation plans, study management, and the proposed methods of analysis that will be performed on the collected data. Protocol Amendment: Changes or clarifications made in writing to the original protocol. Radioactive Materials: Radioactive materials includes radioactive drugs, any substance defined as a drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons, including any non-radioactive reagent kit or nuclide generator that is intended to be used in the preparation of a radioactive drug. Drugs containing trace quantities of naturally occurring radio-nuclides are not considered radioactive drugs. Recruitment: Planned outreach program and the method for attracting subjects into a study, and the act of enrolling subjects with the proper inclusion criteria. Research: A systematic investigation, including research development, testing or evaluation designed to develop or contribute to generalizable knowledge. Such activity may or may not differ in any significant way from customary medical or other professional practice. Research extends to clinical research regulated by the FDA as well as clinical research that supports applications for research or marketing permits for products regulated by the FDA, including drugs, medical devices, and biological products for human use. Risk: The probability of harm or injury (including 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. Safety Reports: Written report to the FDA required for any serious and unexpected adverse experience associated with the use of the drug. Serious Adverse Event: Any adverse experience associated with the study article that results in any of the following outcomes: death, a life-threatening experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Severely Debilitating: Diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke. Special Population: Particularly vulnerable subjects including children, prisoners, pregnant women, cognitively impaired persons, or educationally disadvantaged persons who require special consideration to protect their welfare. Sponsor: Individual, company, institution or organization that initiates a clinical investigation and takes responsibility for the management and financing of the study. Subject: Participant in a study. See Human Subject. Unexpected Adverse Event: Any adverse experience associated with the study article for which 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 current application, as amended. "Unexpected" refers to an adverse experience that has not been previously observed. Voluntary: Free of coercion, duress, or undue inducement. Vulnerable Subjects: Refers to subjects who may be unduly influenced to participate (e.g., students, subordinates and patients). See Special Population.
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