IRB APPLICATION INSTRUCTIONS

The Mount Auburn Hospital Institutional Review Board (IRB) reviews protocols according to the level of risk to research subjects involved and categories of research as defined by federal regulations 45 CFR Part 46 and 21 CFR Part 50. The proposed research may present more than minimal risk to subjects (full board review), minimal risk (expedited review), or the research may qualify as exempt under specific categories 46.101(b)(1-6), 46.201(b), 46.301(a), 46.401(b), 21 CFR 50.104.

The type of review will determine the research application requirements.

For all protocols that involve any contact with human subjects whether through procedures, questionnaires, surveys, interviews, focus groups, sample tissue, cell lines or any material or data that may or may not be linked to human subjects, a determination must be made through the IRB office whether the proposal meets the definition of research with human subjects and whether subsequent IRB review is required.

The IRB Administrator pre-reviews all application submissions and determines whether the research project meets the definition of research involving human subjects. The IRB Administrator is available to consult informally in preparation of a protocol. However, if an investigator would like to consult with the Administrator to determine whether a research project fits a specific category of research, a detailed protocol with all relevant attachments will be required. The IRB Administrator may request additional documents as necessary to make an appropriate recommendation.

Please review the categories of research:

• Full Board Review
• Expedited Research
• Exempt Research

Failure to do so will delay your review. Your application will not be processed unless all required documents are completed, submitted together, signed by your department chair, and reviewed by Research Administration.

If you have questions regarding which forms to complete for your study call the IRB/Research Administration office at 617-499-5774.