Miguela Caniza, MD

    St. Jude and El Salvador create research ethics committee

    The establishment of research ethics committees in El Salvador will enhance that country’s ability to undertake clinical trials aimed at improving cure rates of pediatric catastrophic diseases, according to St. Jude investigators who helped to establish those committees.

    The new programs not only ensure rigorous ethical oversight of research involving human participants but also serve as a model for other institutions in high-income countries to create or strengthen existing research ethics committees in low-income countries. A report on establishment of these research ethics committees (REC) in El Salvador appears in the December issue of Lancet Oncology.

    Establishment of the REC is important because investigators in low-income countries often have little or no access to such groups, said Miguela Caniza, MD, of Infectious Diseases and International Outreach. Yet, research institutions in high-income countries require that an REC be in place before they collaborate with international partners. “So the absence of such RECs either restricts or prevents just the collaborative research needed to help improve medical care in countries with limited resources,” said Caniza, the report’s senior author.

    The El Salvador REC enabled the Hospital Nacional de Niños Benjamin Bloom in San Salvador to collaborate with St. Jude on two projects: research into the effect of nutrition on the immune systems of Salvadoran children and their susceptibility to dengue hemorrhagic fever (a potentially deadly virus infection); and the training of 100 Salvadoran nurses to care for patients with HIV/AIDS.

    The initial success of the REC approach encouraged other institutions in El Salvador to imitate this model and prompted the Salvadoran government to form a national committee to guide ethical research throughout the country. Building on the success in El Salvador, the St. Jude team recently established an REC in Paraguay.

    To promote the continuity of REC collaboration in El Salvador, the researchers exchange information and offer ongoing mentoring of REC members. Part of that mentoring and education is done through the St. Jude Cure4Kids Web site.

    “Our experience with El Salvador has prompted us to consider whether we could communicate the required information for ethical consent more simply and concisely in low-income countries,” Caniza said. “And if so, whether that would that help us to improve the informed consent process used in high-income countries. But the most important basis for establishing ethically responsible international clinical research is the fund of good relations that builds up during these collaborations.”

    Other St. Jude authors include Scott Howard, MD, International Outreach, and Raymond Barfield, MD, PhD, Bone Marrow Transplantation.

    January 2007