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 grant approval office was helpful and the matter was resolved amicably.
For my IRB, this experience highlighted the necessity of conducting regular trainings and creating awareness among researchers and IRB members about the importance of protocol documents and on-time submissions. If PIs lack knowledge about IRB procedures, they may show a lack of respect for the process, which may cause conflict.
A webinar hosted by PRIM&R, titled Working through Conflict: Helping IRB Staff Communicate Effectively with Investigators, that I recently attended helped to reinforce the importance of education and communication in the research process. The presentation reminded me that investigators need to keep in mind that IRBs are charged with facilitating safe, ethical, high quality research within the scope of existing regulations, while IRBs should do their best to treat researchers as customers and demonstrate that the IRB is on the client’s side by maintaining open, honest, and transparent communication. Consider the words of science writer Atif Kukaswadia: “If we want to bring people together, we have to avoid using language that drives us apart. If we want to promote science, we have to discourage hate. And if we want to educate others, we first have to start by understanding others.” Ultimately, a collaborative approach among IRBs, IRB staff, and investigators helps everyone work toward the common goal of protecting research participants and moving science forward.