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Tissue Collection for Correlative Studies in Childhood Cancer Clinical Trials: Ethical Considerations and Special Imperatives

From the National Cancer Institute, Cancer Therapy Evaluation Program, Rockville; The Children's Cause Inc, Silver Spring, MD; Memorial Sloan-Kettering Cancer Center, New York, NY; and Children's Oncology Group Phase I Consortium, Arcadia, CA.

Address reprint requests to Barry D. Anderson, MD, PhD, National Cancer Institute, Cancer Therapy Evaluation Program, 6130 Executive Blvd, EPN 7025, Rockville, MD 20892-7436; e-mail: andersonb{at}ctep.nci.nih.gov

ABSTRACT: Federal regulations prescribe distinct protections for children participating in research studies. Procedures for collecting tissue specimens from children solely for research purposes must pose no more than a minor increase over minimum risk, thereby limiting the approvable correlative biologic studies to evaluate molecularly targeted agents in children with cancer. Ethical issues arise when approvable correlative studies are a mandatory component of an early-phase pediatric clinical trial of new anticancer agents. The National Cancer Institute Cancer Therapy Evaluation Program sponsored a workshop in 2002 to discuss tissue collection for correlative biologic studies in early-phase childhood cancer clinical studies of molecularly targeted agents. Workshop participants recommended the following: (1) tissue specimens for correlative studies should provide vital clinical and scientific results to qualify for early-phase pediatric study consideration; (2) parents should receive a realistic appraisal of the risks, requirements, and potential for benefit of phase I protocol participation; (3) investigators should clearly distinguish clinically necessary procedures from research procedures of no benefit to the child to improve correlative study informed consent; and (4) participation in correlative research studies included in clinical trials generally should be voluntary. The need to acquire important biologic data regarding new molecular agents will challenge the ingenuity of pediatric cancer researchers, necessitating the application of highly sensitive laboratory assay methods, new imaging procedures, and preclinical models of childhood cancer. Such innovative methods can allow necessary scientific information to be obtained while simultaneously respecting the protections appropriately afforded to children participating in research studies and minimizing the burden of research participation for children with cancer and their families.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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