Institutional Review Board

Student Handbook on Human Subject Research

August 2006

Ongoing Review of Research

Once a study has been approved by the IRB, the research can begin. The approval is based on the condition that the research activities will be carried out exactly as stated in the proposal. If the student and faculty mentor want to change the stated research activities in any way, they must submit a Protocol Revision or Amendment Form (PRAF). The PRAF includes descriptions of any protocol changes. The PRAF must be reviewed in the same manner as was the initial research proposal. No changes in the research activities can occur until a PRAF has been submitted, reviewed, and approved. PRAF forms must be submitted any time an approved research proposal is changed.

Researchers must submit a proposal for continuing review and approval of research that will last longer than the initial approval period. Usually, the IRB approves research proposals for a period of up to one year, however, sometimes shorter approvals may be granted. For example, if a study has multiple stages, the IRB may want to review the research proposal at the end of each stage, even if the stage is a few weeks or months long. Within 60 days of the end date of the initial approval, the faculty mentor and student will be notified by e-mail and must submit the IRB Continuing Review/Study Completion Form. This form must also be completed when the study is terminated, even if the termination occurs during the initial year of approval. Researchers are also required to notify the ORC if something harmful, undesirable, or unexpected happens as a result of research activities. When a harmful, undesirable, or unexpected incident happens as a result of research, it is known as an adverse event. When this happens, the faculty mentor and student must submit the Adverse Event Report Form to the ORC. In short, the ORC needs to know when the study starts, when it ends, if you want to make changes, and if an adverse event happens during the study.