HRP-001-Definitions

Sep 19, 2026

HRP-001-Definitions establishes formal definitions used by the University of Georgia’s Human Research Protection Program. It clarifies key terms that govern human subjects research administration, including roles involved in alternate review workflows, criteria for “adult,” and the meaning of “adverse event” and associated harms. The definitions also cover institutional relationships, reviewer membership and affiliation concepts, research authorization under HIPAA, and protections such as Certificates of Confidentiality, plus related terminology like minors and clinical investigation.

LanguageEnglish

CategoryGeneral

FormatPDF

Pages13

Reading Time5 min

AccessFree to download

HRP-001-Definitions

Administrative Reviewer

Adult

Adverse event

Affiliated Institution

Affiliated IRB Member

Affiliation

Agenda

Agents

Alternate Member

Authorization (HIPAA)

Autonomy

Business Associate

Certificate of Confidentiality (CoC)

Child (Children)

Clinical Investigation (FDA)

Coercion

Collaborating Site

Collaborative Institutional Training Initiative (CITI)

HRP-001-Definitions This document establishes the definitions followed by the University of Georgia’s Human Research Protection Program. 1. Administrative Reviewer: refers to the person assigned to complete one of three alternate workflows: 1) determination of human subject research, 2) review of a project in development, or 3) review and processing of research that requires reliance upon an External IRB. This is usually the IRB Director or Assistant Director. 2. Adult: is a person who by virtue of attaining a certain age is regarded in the eyes of the law as being able to manage his or her own affairs. For the purposes of this policy, an adult is defined in the location where the research will take place. In Georgia, an adult is an individual who is 18 years of age or older. 3. Adverse event: 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 (modified from the definition of adverse events in the 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice) . Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research. 4. Affiliated Institution: a hospital or institution in the vicinity of UGA which does not have an internal IRB and where an existing Memorandum of Understanding or Agreement exists between UGA and the affiliated institution designating UGA IRB as the Reviewing IRB. 5. Affiliated IRB Member: a UGA employee or agent (or a member of this person’s immediate family) . They include, but are not limited to, individuals who are: part-time employees; current students; members of any governing panel or board of the institution; paid or unpaid consultants; healthcare providers holding credentials to practice at the institution; and volunteers working at the institution on business unrelated to the IRB. 6. Affiliation: an individual’s relationship to a site through employment, enrollment, membership, or other similar means. 7. Agenda: a document that describes the topics of discussion for the IRB meeting. 8. Agents: are employees and individuals who: (1) act on behalf of an institution; (2) exercise institutional authority of responsibility; or (3) perform institutionally designated activities; can include faculty, staff, students, authorized affiliates, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation. An “authorized affiliate” is an individual granted research privileges at UGA by a department or college. 9. Alternate Member: a member who is designated to substitute for a regular IRB member for an entire meeting or at any time during a meeting. Alternate members have qualifications comparable to the applicable regular member and may serve as alternate for more than one regular IRB member. 10. Authorization: under HIPAA, is an individual's signed permission that allows a covered entity to use or disclose the individual's PHI for the purposes and to the recipient(s) as stated in the Authorization. Also: HIPAA Authorization. 11. Autonomy: is defined as the personal capacity to consider alternatives, make choices, and act without undue influence or interference of others. 12. Business Associate: in general, is a person or organization, other than a member of a covered entity's workforce, who acts on behalf of, or provides certain services to, a covered entity that involves the use or disclosure of PHI. 13. Certificate of Confidentiality (CoC): allows the investigator and others who have access to research records to refuse to disclose identifying information in any civil, criminal, admi

FAQs

What is an “Administrative Reviewer” in the HRP-001 definitions?

It is the person assigned to complete one of three alternate workflows, such as determining whether a project is human subject research, reviewing developed projects, or processing research that relies on an External IRB.

How does the document define an “Adult” for the purposes of the policy?

An adult is defined by the location where the research takes place; in Georgia, it means an individual aged 18 or older.

What does “Adverse event” include under these definitions?

An adverse event is any untoward or unfavorable medical occurrence, including abnormal signs, symptoms, or diseases temporally associated with participation, covering both physical and psychological harms.

Sep 19, 2026

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