R495-820-3 - Definitions

R495-820-3. Definitions

(1) The definitions found in the United States federal regulations at 45 CFR 46 (January 15, 2009), 21 CFR 50 (April 1, 2014), 21 CFR 56 (April 1, 2014), 21 CFR 312 (April 1, 2014), 21 CFR 812 (April 1, 2014), and 45 CFR 164 (October 1, 2007) are incorporated by reference, including by not limited to:

(a) "Human subject" defined in 45 CFR 46.102.

(b) "Legally Authorized Representative" defined in 45 CFR 46.102.

(c) "Minimal risk" defined in 45 CFR 46.102.

(d) "Phase I study" defined in 21 CFR 312.21.

(e) "Phase II study" defined in 21 CFR 312.21.

(f) "Phase III study" defined in 21 CFR 312.21.

(g) "Research" defined in 45 CFR 46.102.

(2) The following are defined for purposes of this section.

(a) "Adverse Event" means any unfavorable incident or unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with enrollment in a research study, whether or not considered related to the product, intervention, or treatment being tested. An adverse event also means any emotional distress, psychological trauma, invasion of privacy, embarrassment, loss of social status or employment, or economic impact that may be related to participation in the research.

(b) "Serious Adverse Event" means an adverse event that results in any of the following:

(i) Death, or a life threatening event;

(ii) Inpatient hospitalization or prolongation of existing hospitalization;

(iii) Significant, persistent, or permanent harm or disability either physically or psychologically;

(iv) A congenital anomaly or a birth defect; or

(v) Any medically significant event that may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

(c) "Conflict of Interest" means any situation where the researcher has financial, economic, social, political, familial, legal or other interests which interfere with, or have the potential to interfere with, their judgment in connection with the research.

(d) "Department" means the Utah State Department of Human Services, also referred to as DHS.

(e) "Department's employee" means anyone who has been hired into a full or part-time position whether merit or non-merit with the Department, and for the purposes of this Rule includes any volunteer, student intern, or individual serving a field practicum with the Department.

(f) "DHS IRB" means the Department's Institutional Review Board.

(g) "Division" means any of the Department's divisions, offices, or agencies.

(h) "Foreseeable Risk" means any risk the researcher or sponsor knew, or should have known, would pose a risk to human research subjects.

(i) "Gatekeeper" means the Division Representative on the IRB who serves as the primary reviewer and liaison between researchers and the Department.

(j) "Guardian" means a person who is legally qualified as a guardian of a minor or incapacitated person, but excludes a Guardian ad Litem.

(k) "Less than minimal risk" research refers to research in which the researcher will not contact the human subject in person, but may request access to client or employee data maintained by the Department or its contractors, and the risk of harm or discomfort to the human subject is less than minimal risk as defined in 45 CFR 46.102.

(l) "Serious mental illness" means Major Depression, Bipolar Disorder, Schizophrenia, Dissociative Disorder, other psychotic illnesses, Attention-Deficit Hyperactivity Disorder, Post Traumatic Stress Disorder, Borderline Personality Disorder, Reactive Attachment Disorder, and Panic Disorder.

(m) "Proposal" means the application completed by the researcher and submitted to the division gatekeeper for consideration.

(n) "Publicly-funded client population" means individuals receiving services funded directly or indirectly by the Department, including clients' family members, clients' victims, or local community mental health, substance abuse, and aging and adult service consumers where the local agency receives pass-through funds from the Department to provide services to the community.

(o) "Researcher" means anyone seeking to access data or recruit clients or employees of the Department for research purposes, and anyone proposing or conducting research activities. This may include the researcher's employees, staff, or assistants.

(p) "Review Determination" means the outcome of an IRB review which may be any of the following:

(i) "Final Approval" means the determination of the DHS IRB that the research has been reviewed and may be conducted within the constraints set forth by the DHS IRB.

(ii) "Conditional approval" means the DHS IRB requires specific revisions or verifications before final approval will be granted. Conditional approval does not authorize research activities, including but not limited to subject contact or recruitment, to proceed.

(iii) "Deferred Decision" means the DHS IRB did not have sufficient information to complete a review. The DHS IRB may review the research proposal at a future time after the DHS IRB receives sufficient information.

(iv) "Disapproval" means the DHS IRB denies the proposal and will not approve the proposal, with or without changes.

(v) "Exempt" means the proposal does not qualify as research as defined in 45 CFR 46.102 and in accordance with 45 CFR 46.101 and is not subject to ongoing DHS IRB oversight. Exempt status is determined by the DHS IRB or gatekeeper.

(q) "Vulnerable adult" is as defined in UCA 62A-3-301.

(Adopted by Utah State Bulletin Number 2015-14, effective 6/18/2015)

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