Researchers must determine whether IRB review is warranted for their project. To assist with this evaluation, consult the resources in the “how do I apply?” and “coursework that involves research” sections, and/or this decision tool from HHS.
Once a researcher determines that IRB review is appropriate for their project, they must submit an application for review and receive approval before they begin their research. This is crucial as IRBs may not retroactively approve a project once it has begun.
Before applying, researchers should review the College’s IRB policies. Furthermore, researchers should review guidance on informed consent as well as the application itself to identify which supporting documents should be included in the submission. Researchers seeking an orientation to the IRB’s work, in general, may review this video lecture. Typically, researchers will need to include materials associated with their proposed intervention (e.g., a copy of the questionnaire or survey questions and documents supporting recruitment efforts) and a consent or disclosure form. Students who apply must also include a Research Advisor form and ensure that their advisor has worked with them to prepare their application, as described in the Research Advisor Responsibilities. There are templates for several commonly included documents that researchers may adapt to the needs of their proposed study. Finally, researchers may refer to the glossary for additional guidance as they navigate the application process.
Once submitted, the IRB will review the application and supporting materials. Researchers may not begin the proposed activities until they have received official approval from the IRB.
In general, the IRB considers the following factors in reviewing research proposals:
- Whether the risks to the participant are reasonable when weighed against possible benefits to the participant and the importance of the knowledge expected to be gained by the research;
- Whether the risks to the participants are minimized;
- Whether the selection of participants is equitable (e.g., free from racial, gender or other types of bias);
- Whether arrangements are made to ensure that the informed consent of participants is obtained and, where required by law or these regulations, documented;
- Whether the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects, when appropriate;
- Whether there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data, when appropriate;
- Whether any of the participants are vulnerable to coercion or undue influence; and
- Whether there are provisions for monitoring data when necessary to protect human subjects.
Researchers may review other sections to address questions regarding what happens after they apply and their obligations as investigators after approval. Additional guidance is detailed in the investigator responsibilities section.