Knowing what to expect and what is expected from the investigator will facilitate a smooth and timely application process. Below are some of the steps and the resources available to investigators, so that they can ensure that their research applications are complete and well-prepared.
Prior to starting a research project, investigators must obtain the appropriate approvals from the departments involved in the study, as well as from the ancillary reviews (contracts and budgets). These approvals signal that the research submitted meets all institutional requirements for review and the departments involved agree to be a part of the research being conducted.
After the application has received the appropriate sign-offs, it moves on to the Office of Research Integrity for the human research protection review. At that point, a staff member ensures that the investigators and study team members have completed their required CITI training and that they have completed their Conflict of Interest forms. Once those have been verified, the application undergoes a staff member pre-review to ensure that all of the basic elements of the application are present and consistent. Lastly, if applicable, the application is sent to the relevant committee(s) for approval. The investigator may only commence his or her research upon receipt of an approval letter and must adhere to any requirements that may be relevant during the course of the study, such as submitting continuing reviews or amendments.