by Veena Joshi, PhD, Independent Consultant, India
During my previous job at a tertiary hospital in India, a pediatrician from the institution approached the IRB office with a grant proposal. He wished to conduct a study with children under 12 years of age. While he had reviewed information online about the necessary documentation and regulatory requirements, he still sought the help of the IRB office since it was his first time serving as a principal investigator (PI).
Upon reviewing his documents, the IRB administrative staff found that the assent form was missing. The PI was not aware that an assent form was required for participants under 18 years of age. The staff also noticed that the translated, local language version of the study was not easy for a layperson to understand. The IRB staff recommended that the translation be improved with the help of a translator appointed by the research department. The IRB staff also asked the PI to submit the necessary documents to the IRB office by a specific deadline.
Unfortunately, the PI was not able to submit the documents by the deadline, which resulted in his protocol being excluded from the agenda for the next IRB meeting. This upset the PI—he felt he had checked all the documents and he was hoping to have a grant approved for his research. The IRB manager assured him that they would work with him to come up with a solution. The IRB manager called the grant approval office and asked them to hold on to this particular protocol as it was with the IRB office, and would certainly get reviewed during their next meeting.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.