COVID19 & Research Activities

OVCR Research-Related Updates Regarding COVID19 Emergency and Research Activities

Glossary

Term Definition
Assent A child's affirmative agreement to participate in research. The child’s failure to object, absent affirmative agreement, should not be considered assent.
Child / Children / Minor The federal research regulations define children as individuals who have not attained the legal age for consent to treatments or procedures involved in the research, under the State or local law of the jurisdiction in which the research will be conducted. In Illinois, individuals under the age of 18 are considered minors with certain exceptions.
Clinical Investigation Any experiment in which a drug (or biologic or device) is administered or dispensed to, or used involving, one or more human subjects. In this context, experiment refers to any use of a drug except for the use of a marketed drug in the course of medical practice. (21 CFR 312.3(b))
Federal Wide Assurance (FWA) An agreement between DHHS and UIC that UIC will review and approve federally funded research involving human subjects in accordance with the ethical principles outlined in The Belmont Report and the DHHS regulations [45 CFR 46]. UIC's FWA # is #00000083.
Foster Child In Illinois, a foster child is a ward of the state since the Illinois Department of Children and Family Services, an Illinois state agency, holds guardianship of the person for foster children. (Juvenile Court Act of 1987, 705 ILCS 405; Children and Family Services Act, 20 ILCS 505).
Generalizable knowledge The extent to which research findings and conclusions from a study conducted on a sample population can be applied to the population at large (i.e., extending the results beyond a single individual or an internal unit).
Guardian An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care. In Illinois, the term Guardian “means a court appointed guardian of the person who serves as a representative of a minor or as a representative of a person under legal disability.” In Illinois, a variety of guardianship appointments exist and the investigator should take care to document that the guardian’s representation of the ward is within the scope of their authority: limited guardianship, plenary guardianship, guardian of the person, guardian of the estate, and temporary guardianship. (Health Care Surrogate Act, 755 ILCS 40; Juvenile Court Act of 1987, 705 ILCS 405/1-2).
Guardianship of the Person of a Minor In Illinois, the duty and authority to act in the best interests of the minor, subject to residual parental rights and responsibilities, to make important decisions in matters having permanent effect on the life and development of the minor and to be concerned with their general welfare. It is includes but is not necessarily limited to . . . the authority to consent to major medical, psychiatric, and surgical treatment. (Juvenile Court Act of 1987, 705 ILCS 405/1-2). Please contact OPRS for guidance in temporary custody situations or for children who are placed by court under the guardianship of a probation officer, as these are complex situations that may require the advice of University Counsel.
Human Protections Administrator (HPA) The primary contact person for human subject protection issues, including the investigation and reporting of non-compliance matters, and plays a key role in ensuring that UIC fulfills its responsibilities under its FWA. At UIC, the HPA is the Director of the Office for the Protection of Research Subjects (OPRS).
Human Subject A living individual about whom an investigator (whether professional or student) conducting research (1) obtains data or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the data or biospecimens, or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. [45 CFR 46.102(e)(1)]
Identifiable biospecimen A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. [45 CFR 46.102(e)(6)]
Identifiable private information Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. [45 CFR 46.102(e)(5)]
Institutional Official (IO) The individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Federalwide Assurance (FWA). At UIC, the Vice Chancellor for Research is the IO.
Interaction Communication or interpersonal contact between investigator and subject. [45 CFR 46.102(e)(3)]
Intervention Includes both physical procedures by which data or biospecimens 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(e)(2)]
Private Information 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). [45 CFR 46.102(e)(4)]
Research A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities deemed not to be research are specified in the UIC HSPP policy Determination Whether an Activity Represents Human Subjects Research at UIC.
Research (DoD) The DoD defines "research" as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Systematic investigation A project that is planned in advance and that uses data collection and analysis to answer a specific question, testing a specific hypothesis, or developing a theory.
Voluntary 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.
Ward Any child who is placed in the legal custody of the state or other agency, institution, or entity, consistent with the applicable federal, state, and local laws and regulations. In Illinois, a ward of the state includes but is not limited to a child placed by court under the guardianship of the Illinois Department of Children and Family Services. In Illinois, children placed in foster care are wards of the state. (Juvenile Court Act of 1987, 705 ILCS 405/ 2-7).