Instituting assent for minors in a local IRB within a developing country

Issues: Protection of human subjects involved in research in developing countries requires approval from Institutional Review Boards (IRBs) at the sponsoring institution and the local site. Local IRBs are essential to protect the rights of volunteers involved in research, particularly concerning projects conducted in developing countries. However, ethical recommendations by the local IRBs may differ from federal regulations in the sponsoring institution's country.

Description: US Federal regulations (45 CFR 46 Subpart D and FDA guidance on assent of children for enrolling minors) require that adequate provision be made for soliciting the assent of children when they are capable of providing assent. In accordance with US Federal regulations, Assent for Minors was included in the enrollment protocol for a study on oral manifestations of HIV Infection in Haitian children and adolescents. The study protocol was approved by the sponsoring institution IRB. However, Assent for Minors led to the following concerns from the local IRB: substitution of informed consent with Assent for Minors, coercion of minors to sign Assent, and assenting minors in the absence of parent/guardian supervision.

Lessons Learned: Clarifying how Assent for Minors protects minors against coercion extended the local IRB approval process by 3 months. The local IRB judged Assent for Minors an ethical standard to institute independent of the justifications by the US Federal regulations.

Recommendations: Novel institution of Assent for Minors in the local IRB illustrates the complexity of adhering to evolving US federal guidelines when conducting research in a developing country setting.