Page 305 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q020
SOP Title: Adult Research Patient at Children’s Health
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe Children’s HealthSM institutional policy AD 7.07 “Acceptance of Adult Research Patients” and the steps involved to identify, track, and route these projects to Research Compliance Subcommittee voting members, and other key stakeholders as applicable, for review and approval consideration.
2. ELIGIBILITY DETERMINATION
Children’s HealthSM will only approve clinical research studies on patients 19 years of age and over, when those studies:
1. provide a therapeutic intervention that offer the prospect of direct benefit for the patient,
2. will recruit and treat patients who have an existing or should have a treatment relationship with a Children’s Health program (e.g., congenital heart defect program),
3. align with the clinical competencies of the Children’s Health team members so that we will be able to provide the appropriate care, treatment and services,
4. are part of a pediatric research study program (e.g., Children’s Oncology Group study) and are only awarded to pediatric institutions
.
Children’s Health will not approve clinical research studies on patients 19 years of age and over, when those studies:
1. may provide generalized benefit to the pediatric population,
2. are contingent on the use of a specific piece of Children’s Health equipment or
resource with no clear therapeutic benefit to our patients,
3. do not align with the Children’s Health mission and strategic vision.
3. EXAMPLES OF PROJECTS
Examples of Studies that meet the requirement:
1. Prospective drug, device studies (inpatient, outpatient) for pediatric and adult patient population (≥ 19 years of age)
2. Prospective studies where imaging modalities are used to assess efficacy of treatment - pediatric and adult patient population (≥ 19 years of age)
Examples of studies that do not meet the requirement:
1. Retrospective Chart Review of Clinical Records
2. Prospective studies Children’s providers (e.g., nurses, PT, etc.)
3. Prospective studies of UTSW providers (e.g., faculty, resident, fellows, medical students, etc.)
4. Prospective studies with patient population < 19 years of age and their parents/LAR
5. Prospective, non-interventional studies (use of survey, questionnaires) where the study population includes ≥ 19 years of age
SOP No. 22, 06-02-22