Page 365 - CHST Research Administration eBook 2 of 2 (Q4 2021)

MEMO
To: Division Directors, Investigators, UT Southwestern Department Administrators From: Research Administration
Date: November 8, 2019
Re: New Policy: AD 7.07 Acceptance of Adult Research Patients
Hello,
The purpose of this memo is to inform you that Children’s Health has established a new policy on enrolling adult research patients on clinical trials/research studies.
Children’s Health 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)
5. are only awarded to pediatric institutions.
Investigators with studies not meeting the criteria above are required to complete/submit the “Adult Research Patient Questionnaire” form (see attached). The form will be reviewed by the Research Compliance Subcommittee and approvals issued by Vice President of Research Administration and the President of System Clinical and Scientific Operations or his/her designee. Determinations will be communicated to the study PI/team by Research Administration.
Please feel free to contact us with any questions at research_department@childrens.com Thank you,
Research Administration