Research Subject Advocacy in the Pediatric Clinical Translational Research Center

from Practice Update, Winter 2007

Terri O’Lonergan,

Research Subject

Advocate

The National Institutes of Health requires each pediatric research center maintain a research subject advocate (RSA) to act in the interest of children involved in clinical research studies. The advocate has the background and experience to ensure that children and their parents or guardians understand all the various requirements of and protections for research participants. The RSA at Children’s Pediatric Clinical Translational Research Center is involved in all phases of the research enterprise, from proposal submission to approval. The RSA provides consultation and assistance to investigators in the design and writing of pediatric research protocols, formulation and writing of data and safety monitoring plans, initiation and conduct of research and creation of data and safety monitoring boards.

While the advocacy program develops policies, procedures and written guidelines for clinical investigators and monitors structures for protocol oversight, its main focus is on individual research participants and their families. The research subject advocate rounds on the CTRC inpatient unit on the fourth floor each morning and speaks with each research participant and their family. Several educational pamphlets are available, in both English and Spanish, for research participants. Rounding and pamphlets help assure that research participants and their families understand both the research in which they participate and their roles and rights.

Increasingly, the RSA is involved in publication and conduct of “research about research,” especially research involving adolescents and the ethical issues involved in pediatric research. Current RSA research involves examination of the protocol review process, acute reactions to venipuncture, and issues surrounding blood volumes drawn in both research and treatment in pediatric populations. 

For more information and access to policies and guidance, go to http://www.uchsc.edu/pedsgcrc/ and click on the “Research Subject Advocacy” button. Also available at this site is information about applying for support for clinical research. The Research Subject Advocate is Terri O’Lonergan. She can be reached at 720-777-1234 or o'lonergan.theresa@tchden.org .