Appendix A – Glossary
ADVERSE EVENT: Any experience that suggests a significant hazard, contraindication, side effect, or precaution; any experience that has taken place during the course of a research project, which, in the opinion of the investigators, was harmful to a subject participating in the research, increased the risks of harm in the research, or had an unfavorable impact on the risk/benefit ratio.
Serious – an event that is fatal or life-threatening, is permanently or significantly disabling, requires or prolongs inpatient hospitalization, or is a congenital anomaly, cancer, or overdose; report to NGHS IRB immediately, with formal written notification to follow within 24 hours of the event
Unanticipated – an adverse event not noted in the consent or ‘Investigator’s Brochure’ or that is more serious than expected.
ADVERTISEMENT: A recruitment effort using the media in a pre-planned way with the intent of informing potential subjects that a trial exists. Under this definition, any print, mailed, radio, television or computer advertisement targeting subjects is an advertisement. Letters, directories or mailers intended for other professionals are not considered subject advertising for purposes of this definition.
FDA IRB Information Sheet, October, 1994, page 20
ANONYMOUS: No identifiers were gathered at the time the sample was acquired and none are connected with the sample. In addition, the sample is not a "one-of –a-kind"; sample that would not be connected demographically or in anyone’s mind with a particular individual.
ASSENT: A child's affirmative agreement to participate in research. Mere failure to object should not (absent affirmative agreement) be construed as assent
21 CFR 46.402(b)
CANCER THERPY EVALUATION PROGRAM (CTEP): A National Cancer Institute program under the Division of Cancer Treatment. This branch designs and implements the development plans for new agents.
CERTIFICATION: The official notification by the institution to the DHHS in accordance with the requirements of this part that a research project or activity involving human subjects has been reviewed and approved by the Institutional Review Board (IRB) in accordance with the approved assurance on file at DHHS. Certification is required when the research is funded by the DHHS and not otherwise exempt in accordance with 21 CFR 46.101(b).
21 CFR 46.102(h)
CHILDREN: Persons who have not attained the legal age of consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted (18 years of age in Georgia), unless an emancipated minor.
21 CFR 46 402(a)
CLINICAL INVESTIGATION: 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 FDA under section 505(i), 507(d), or 520(g) of the act) or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted 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 must meet the provisions of Part 58 regarding non-clinical laboratory studies. The terms, "research," "clinical research," "clinical study," "studies," and "clinical investigation," are deemed to be synonymous for purpose of this part.
21 CFR 56.102(c) and 21 CFR 50.3(c)
CONFIDENTIALITY: Maintaining the privacy and preventing the unauthorized disclosure of information. CRO: Clinical Research Organization EMERGENCY USE: The use of a 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.
21 CFR 56.102(d)
FEDERALWIDE ASSURANCE (FWA): A written agreement between the institution and the DHHS stating, to the satisfaction of the Secretary, DHHS, that the institution will comply with the requirements set forth is 21 CFR 46 and its subparts.
FETUS: The product of conception from the time of implantation (as evidenced by any of the presumptive signs of pregnancy (such as missed menses, or a medically acceptable pregnancy test), until a determination is made, following expulsion or extraction of the fetus, that it is viable.
21 CFR 46.203(c)
FETUS, DEAD: A fetus ex utero which exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord, if still attached
21 CFR 46.203(f)
FETUS, VIABLE: As it pertains to the fetus means being able, after either spontaneous or induced delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist in determining whether a fetus is viable for purposes of this subpart. If a fetus is viable after delivery, it is a premature infant.
21 CFR 46.203(d)
GROUP C DRUGS: FDA may give an investigational drug a Group C designation if it has reproducible efficacy in one or more specific tumor types. Such a drug has altered or is likely to alter the pattern of treatment of the disease and can be safely administered by properly trained physicians without specialized supportive care facilities. Group C drugs are distributed only by the NIH under NCI protocols and are used for treatment of single patients and are not for clinical investigation or clinical trials!
GUARDIAN: An individual who is authorized under applicable state or local law to consent on behalf of a child for general medical care.
(1) An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a health individual or a patient.
21 CFR 56.102(e) and 50.3(g)
(2) A living individual about whom an investigator (whether professional or student) conducting research obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information.
INVESTIGATIONAL DEVICE EXEMPTION (IDE): No device may be placed in interstate commerce for use in medical diagnosis or treatment unless it has been granted a marketing approval by the FDA. An exemption may be granted for an investigational device to be shipped for use in an approved investigation. (21 CFR 812) The IDE may be granted by the IRB if the IRB agrees with a contention posited by the sponsor that the device involved a non-significant risk to the health of the subjects. If the sponsor does not put forward the contention or if the IRB disagrees with it, it is presumed to be a significant risk device that must be approved at the FDA.
INVESTIGATIONAL NEW DRUG (IND): No drug may be placed in interstate commerce for use in medical diagnosis or treatment unless it has been granted a New Drug Approval (NDA) or Abbreviated New Drug Approval (ANDA) by the FDA. An exemption is granted only by the FDA for the use of a drug in the context of an investigational protocol approved by an IRB.
21 CFR 312 INTERACTION: Includes communication or interpersonal contact between investigator and subject.
INTERVENTION: Includes both physical procedures by which data is gathered (for example: venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
INSTITUTION: Any public or private entity or agency (including Federal, State, and other agencies). The term "facility" . . . is deemed to be synonymous with the term "institution."
21 CFR 56.102(f), 50.3(h), and 21 CFR 46.102(c)
INSTITUTIONAL OFFICER: A person designated by the institution to sign multiple or single project assurances.
INSTITUTIONAL REVIEW BOARD (IRB): Any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects.
21 CFR 56.102(g) and 50.3(i)
INVESTIGATOR: an individual who actually conducts clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject) or, in the event of an investigation conducted by a team of individuals, in the responsible leader of that team.
21 CFR 56.102(h) and 50.3(d)
LEGALLY AUTHORIZED REPRESENTATIVE: An individual or judicial or other body authorized under applicable (Georgia) law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
21 CFR 46.102(c) 21 CFR 50.3(m)
MINIMAL RISK: The probability and magnitude of the physical or psychological harm or discomfort anticipated in the research are no greater than those encountered in the daily lives or in the routine medical, dental or psychological examination of healthy persons.
21 CFR 46.102(g) and .303(d) and 21 CFR 50.3(l)
NCI: National Cancer Institute
NIH: National Institutes of Health
OHRP: Office of Human Research Protections PARENT: A child's biological or adoptive parent
21 CFR 46.402(d)
PERMISSION: The agreement of parent(s) or guardian to the participation of their child or ward in research
21 CFR 46.402(c)
PHASE ‘I’ STUDY: The first study of a drug following the pre-clinical animal testing phase. It is the "first time in man" study. NGHS does not have a Phase I facility.
PHASE ‘II’ STUDY: Phase II studies are generally meant to establish the highest dose that can be given without serious side effects. Often the design is a "dose escalation" in which succeeding groups of subjects receive higher doses
PHASE ‘III’ STUDY: The studies that take the most subjects and last the longest. The purpose is to demonstrate that the new product is effective for a group of subjects with the condition for which the drug is intended to be used.
PHASE ‘IIIB’ STUDY: Subjects entered on a Phase III trial may want to stay on the drug after the study is completed and closed and while the data is being readied for presentation. A Phase IIIB study allows "compassionate" use of the drug during this interim time.
PHASE ‘IV’ STUDY: The clinical trials leading to FDA clearance are conducted on small, specialized populations. These trials will not answer question that demand a larger or a broader population.
PLACEBO CONTROLS: An arm of the study receiving something that is not expected to have any activity. Placebo controls may be used only in the rare circumstance where the active arm activity is not expected to be measurable.
PREGNANCY: Encompasses the period of time from confirmation of implantation through any of the presumptive signs of pregnancy (such as missed menses, or by a medically acceptable pregnancy test) until expulsion or extraction of the fetus.
21 CFR 46.203(b)
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 statues or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trail or sentencing.
21 CFR 46.303(c) 12 CFR 50.2(j)
PRIVATE INFORMATION: Includes 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 (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
21 CFR 46.102(f)
RESEARCH: A systematic investigation designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute "research" for purposes of these regulations whether or not they are supported or funded under a program that is considered research for other purposes. For example, some "demonstration: and "service" programs may include research activities.
21 CFR 46.102(e)
RESEARCH STAFF: Staff who have direct and substantive involvement in proposing, performing, reviewing, or reporting research (e.g. investigators, research coordinators, research technicians, research team members, IRB members and staff).
SAFETY REPORTS: ‘Adverse Event’ reports from other sites sent to the sponsor and are then forwarded to the NGHS investigator for transmission to the IRB.
SAMPLE: A representative part from a larger whole or group
De-linked Sample – Identifiers, gained when the sample is collected, are coded before the sample is released to a second party. It is not possible to re-create the link in order to give or receive further information. Linked Sample - Identifiers, gained when the sample is collected, are coded; however, the link has not been destroyed. Information could be returned to or requested from the original sample.
SIGNIFICANT RISK DEVICE: An investigational device that presents a potential for serious risk to the health, safety, or welfare of a subject, and is:
·intended as an implant,
·purported or represented to be for use in supporting or sustaining human life, or
·for a use of substantial importance in diagnosing, curing, mitigating or treating disease, or other wise preventing impairment of human health.
.21 CFR 812.3(m)
SPONSOR: 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.
21 CFR 56.102(j) and 50.3(e)
SPONSOR-INVESTIGATOR: An individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject. The term does not include any person other than an individual; e.g., it does not include a corporation or agency. The obligations of a sponsor-investigator under this part include both those of a sponsor and those of an investigator.
21 CFR 56.102(k) and 50.3(f)
TEST ARTICLE: Any drugs for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product or any other article subject to regulation under the act or under sections 351 or 354-360F of the Public Health Services Act.
21 CFR 56.102(l) and 50.3(k)