Skin Biopsies in Children for the Purpose of Research

Minimal Risk vs. Greater Than Minimal Risk Skin Biopsies

We have published the following guidance for researchers who plan on performing skin biopsies in children for research purposes. This guidance will help researchers consider whether the skin biopsy involves minimal risk or greater than minimal risk and what regulatory requirements are involved.

  • Minimal Risk Skin Biopsy: We have determined that a single skin biopsy <2mm on affected children and children who are healthy controls is a minimal risk procedure.
  • Greater than Minimal Risk Biopsy: We have determined that a single skin biopsy >2mm on affected children as well as children who are healthy controls (see note) is a greater than minimal risk procedure.

Important note: A single skin biopsy >2mm for children who are healthy controls will require additional review. If there is federal funding, the study will be sent to the Department of Health and Human Services for additional review.

IRB Application and Consent Form Sample Language

IRB Application: In the requested information in the following sections. Revise as appropriate.

Consent Form: Include the following information in consent form sections and revise as appropriate.

Additional Information

  • Minimal Risk in Pediatric Research as a Function of Age – Archive Pediatric Adolescent Medicine Arch Pediatr Adolesc Med. 2009;163(2):115-118
  • NHRPAC report – Clarifying Specific Portion of 45 CFR 46 Subpart D that Governs Children’s Research

Last updated: May 9, 2022