This guidance is intended to guide researchers when considering changes to previously approved research to determine review and submission requirements.
In general, changes to previously approved research require review by RCS and/or the IRB prior to implementation to determine whether the study continues to comply with regulatory requirements. The first section of this guidance helps an investigator determine whether an amendment or a new study may be appropriate for the proposed changes. The second section of this guidance helps an investigator determine the submission and review requirements for an amendment based on the level of review.
If a change requires either an amendment or a new study, approval for the changes must be secured prior to implementing changes.
If you must make a change to an approved protocol to eliminate immediate potential hazards to participants, you may do so without prior approval. If you make changes to eliminate immediate potential hazards, contact RCS as soon as possible for further instructions.